Compendium of HPLC Applications for Traditional Chinese

Compendium of HPLC Applications for Traditional Chinese Medicine and Chemical Drugs in China Pharmacopoeia

Compendium of HPLC Applications

for Traditional Chinese Medicine and

Chemical Drugs in China Pharmacopoeia

Preface

This compendium is a collection of analysis methods for traditional

Chinese medicine and chemical drugs in the China Pharmacopoeia,

which use high performance liquid chromatography (HPLC) as the analysis

technique. HPLC was first adopted in the China Pharmacopoeia as an

analysis technique in 1985 on account of its selectivity and sensitivity. The

widespread use of HPLC instrumentation in China has led to an increase

in the adoption of the technique in the China Pharmacopoeia. The 2005

edition included 1366 applications of HPLC, which has now become the

most popular analysis method in the Pharmacopoeia.

This compendium is divided into two parts. The first part describes

HPLC analysis methods for traditional Chinese medicine from Volume I

of the 2005 edition of the China Pharmacopoeia. For many methods,

both the Latin and English names are given. Part two of the compendium

describes the HPLC methods for chemical drugs from Volume II of the

2005 edition of the China Pharmacopoeia.

The page numbers in this compendium correspond to those in the HPLC

Chromatogram Compendium of China Pharmacopoeia, published in 2005

by People's Medical Publishing House, Beijing, China, ISBN 7-117-07114-1.

Disclaimer: Agilent Technologies shall not be liable for errors contained herein or for inci-dental or consequential damages in connection with the furnishing, performance or use of this material. Information, descriptions and specifications in this publication are subject to change without notice.

Japanese Ardisia Herb (Herba Ardisiae Japonicae) ...........3Aifu Nuangong Pills ........................4Anshen Buxin Pills .........................5Anshen Capsules .............................6Anzhong Pian ..................................7Bazhen Yimu Pills ...........................8Bazheng Heji....................................9Chinaroot Greenbrier Rhitome (Rhizoma Smilacis Chinae) .........10Baidai Wan .....................................11White Peony Rooz (Radix Paeoniae) ..........................12Dahurian Angelica Root (Radix Angelicae Dahuricae) ......13Baihe Gujin Wan ...........................14Bailing Jiaonang ............................15Baokening Keli ..............................16Baohe Wan .....................................17Baohe Watered Pills .....................18Baoji Wan .......................................19Biyan Tablets .................................20Biyuanshu Mixture .......................21Malaytea Scurfpea Fruit (Fructus Psoraleae) ......................22Bushen Yinao Tablets ...................23Buzhong Yiqi Watered Pills ..........24Chenxiang Huaqi Pills ..................25Chitong Xiaoyanling Granules ....26Paris Root (Rhizoma Paridis)......27Nippon Yam Rhizome (Rhizoma Dioscoreae Nipponicae) ..............28Chuanxing Chantiao Pills ............29Manyprickle Acanthopanax (Radix et Rhizoma seu Caulis) ....30Extractum Acanthopanacis Senticosi.........................................31Manyprickle Acanthopanax Tablets ............................................32Rhubarb (Radix et Rhizoma Rhei)..............33Extractum Rhei Liquidom ...........34Dahuang Zhechong Pills ..............35Dyers Woad Leaf (Folium Isatidis) ...........................36Danshen Root (Radix et Rhizoma Salviae Miltiorrhizae) ...37Danshen Root (Radix et Rhizoma Salviae Miltiorrhizae) ...38Danle Capsules..............................39Danning Tablets ............................40Chinese Angelica (Radix Angelicae Sinensis) ......................41

Shortscape Fleabane Herb (Herba Erigerontis) ......................42Dengzhan Xixin Injection Fluid ..43Rehmannia Root (Radix Rehmanniae) ....................44Creeping Euphorbia (Herba Euphorbiae Humifusae) ....45Dieda Pills ......................................46Obtuseleaf Erycibe Stem (Caulis Erycibes) ..........................47Dingkun Pills .................................48Pubescent Angelica Root (Radix Angelicae Pubescenti) .....49Duyiwei Capsules .........................50Chinese Clinopodium Granules .........................................51Chinese Clinopodium Tablets .....52Erchen Pills ...................................53Erkangning Syrup .........................54Ertong Qingfei Pills ......................55Curcuma Oils .................................56Fourstamen Stephania Root (Radix Stephaniae Tetrandrae) ...57Thomson Kudzuvine Root (Radix Puerariae Thomsonii) ......58Fenghan Kesou Granules .............59Fubao Granules .............................60Compound Danshen Dripping Pills .................................61Fufang Guazijin Granules ............62Compound Berberine Hydrochloride Tablets..................63Compound Berberine Hydrochloride Tablets..................64Compound Yuxingcao Tablets ....65Fuke Tiaojing Tablets ...................66Fuke Shiwei Tablets .....................67Liquorice Root (Radix et Rhizoma Glycyrrhizae) ................68Liquorice Root (Radix et Rhizoma Glycyrrhizae) ................69Extractum Glycyrrhizae ...............70Extractum Glycyrrhizae Liquidum ........................................71Ganmao Qingre Granules ............72Ganmao Tuire Granules ...............73Gegen Qinlian Pills .......................74Gejie Dingchuan Pills ...................75Gentongping Granules .................76Chinese Mahonia Stem (Caulis Mahoniae) ........................77Gongxuening Capsules ................78Guben Kechuan Tablets ...............79

Amur Coork Tree (Cortex Phello-dendri Amurensis) ........................80Guishao Dihuang Pills ..................81Guishao Dihuang Pills ..................82Guifu Dihuang Pills.......................83Guifu Dihuang Pills.......................84Guilin Xiguashuang ......................85Lotus Leaf (Folium Nelumbinis) .86Heye Pills .......................................87Bigflower Rhodiola Root (Radix et Rhizoma Rhodiolae).................88Red Ginseng (Radix et Rhizoma Ginseng Rubra) .............................89Officinal Magnolia Flower (Flos Magnoliae Officinalis) ........90Common Fenugreek Seed (Semen Trigonellae) .....................91Giant Knotweed (Rhizoma et Radix Polygoni Cuspidati) ...........92Giant Knotweed (Rhizoma et Radix Polygoni Cuspidati) ...........93Hugan Tablets................................94Pagodatree Flower (Flos Sophorae) ............................95Huaijiao Pills .................................96Chinese Cork Tree (Cortex Phellodendri Chinensis) .............97Huanglian Shangqing Pills ...........98Milkvetch Root (Radix Astragali) ..........................99Baical Skullcap Extrtact (Extractum Scutellariae Siccus) ..........................................100Huixiang Juhe Pills .....................101Huoxue Zhitong Powder ............102Huoxiang Zhengqi Oral Liquid ..103Huoxiang Zhengqi Soft Capsules .......................................104Huoxiang Zhengqi Tincture .......105Jiawei Xiaoyao Pills ....................106Jianmin Yanhou Tablets .............107Jianwei Xiaoshi Tablets .............108Turmeric (Rhizoma Curcumae Longae) .....................109Jinguo Tablets .............................110Common Clubmoss Herb (Herba Lysimachiae) ..................111Jinsang Liyan Pills ......................112Jinsang Sanjie Pills .....................113Japanese Honeysuckle Flower (Flos Lonicerae Japonicae) .......114Jingzhi guanxin Tablets ..............115Jingfukang Granules ...................116

I

Contents

Jiuqi Niantong Pills .....................117Jiuwei Qianghuo Pills .................118Red Tangerine Peel (Exocarpium Citri Rubrum) ......119Juhong Tanke Mixture ...............120Juhong Pills .................................121Cassia Seed (Semen Cassiae)....122Kaixiong Shunqi Pills .................123Kanggan Granules .......................124Kanggu Zengsheng Capsules .....125Kouyanqing Granules .................126Lightyellow Sophora Root (Radix sophorae Flavescentis) .127Lidan Paishi Tablets ...................128Weeping Forsythia Extract (Extractum Forsythiae Siccus) .129Lingyang Ganmao Tablets .........130Lingyang Qingfei Pills.................131Liuwei Dihuang Pills...................132Liuwei Dihuang Pills...................133Liuying Pills .................................134Longdan Xiegan Pills ..................135Longqing Tablets .........................136Aloe...............................................137Lusika Pills ..................................138Dogbane Leaf (Folium Apocyni Veneti) ............139Ephedra Herb (Herba Ephedrae) .......................140Maren Runchang Pills ................141Maren Pills ..................................142Maiwei Dihuang Pills ..................143Maiwei Dihuang Pills ..................144Shrub Chasetree Fruit (Fructus Viticis) ..........................145Meihua Dianshe Pills ..................146Mingmu Dihuang Pills ................147Mingmu Dihuang Pills ................148Tree Peony Bark (Cortex Moutan) .........................149Clove Fruit (Fructus Caryophylli) .................150Common Aucklandia Root (Radix Aucklandiae) ..................151Common Scouring Rush Herb (Herba Equiseti Hiemalis) .........152Naodesheng Tablets ...................153Naolejing Syrup ...........................154Bovine Bezoar (Calculus Bovis)..........................155Niuhuang Jiangya Capsules .......156Niuhuang Jiangya Capsules .......157Niuhuang Jiangya Pills ...............158

Niuhuang Jiangya Pills ...............159Niuhuang Jiedu Tablets ..............160Niuhuang Jiedu Pills ...................161Niuhuang Qianjin Powder .........162Niuhuang Shangqing Pills ..........163Niuhuang Xiaoyan Tablets .........164Qiju Dihuang Pills .......................165Qiju Dihuang Pills .......................166Qipi Pills .......................................167Qizhi Weitong Keli ......................168Qiangjin Zhidai Pills (Watered Pills) ............................169Pharbitis Seed (Semen Pharbitidis)....................170Qinlian Tablets ............................171Ash Bark (Cortex Fraxini) .........172Qingfei Yihuo Pills ......................173Orientvine Stem (Caulis Sinomenii) ......................174Qingguo Pills ...............................175Qinghou Liyan Granules ...........176Qinghouyan Mixture ...................177Qinglin Granules .........................178Qingning Pills ..............................179Qingwen Jiedu Pills ....................180Qingxuan Pills .............................181Mile Swertia Tablets ...................182Qingyin Pills ................................183Reyanning Granules ...................184Renqing Mangjue Pills ................185Ginseng (Radix et Rhizoma Ginseng) .....186Renshen Jianpi Pills ...................187Renshen Yangrong Pills .............188Renshen Zaizao Pills...................189Honeysuckle Stem (Caulis Lonicerae Japonicae) ....190Cistanche Herb (Herba Cistanches) .....................191Cassia Bark (Cortex Cinnamomi) ..................192Ruyi Jinhuang Powder ...............193Rukuaixiao Tablets .....................194Sanbao Capsules .........................195Sanjin Tablets ..............................196Sanchi (Radix et Rhizoma Notoginseng) ...............................197Sanqi Tablets ...............................198Sanqi Shangyao Tablets .............199Sangju Ganmao Tablets .............200Mulberry Leaf (Folium Mori) ....201Asiatic Cornelian Cherry Fruit (Fructus Corni) ....202

Shaoshangling Tincture .............203Common Cnidium Fruit (Fructus Cnidii) ..........................204Blackberrylily Rhizome (Rhizoma Belamcandae)............205Shenjing Zhike Pills ....................206Shenqi Wuweizi Tablets .............207Shensu Pills .................................208Shengxue Pills .............................209Shiquan Dabu Pills ......................210Shearers Pyrrosia Leaf (Folium Pyrrosiae) .....................211Shugan Hewei Pills .....................212Shugan Pills .................................213Shuanghuanglian Granules ........214Shuanghuanglian Mixture ..........215Shuanghuanglian Mixture ..........216Shuanghuanglian Mixture ..........217Shuanghuanglian Tablets ...........218Shuanghuanglian Tablets ...........219Silybum Marianum Fruit (Fructus Silybi) ...........................220Sishen Pills ..................................221Siwu Mixture ...............................222Sizheng Pills ................................223Songling Xuemaikang Capsules .......................................224Buckeye Seed (Semen Aesculi) ..........................225Snow Lotus Herb (Herba Saussureae Involucratae) ..........226Tiaojing Cuyun Pills ....................227Tongtian Mixture ........................228Tongxinluo Capsules ..................229Tongxuan Lifei Pills ....................230Golden Larch Bark (Cortex Pseudolaricis) ...............231Fimbriate Orostachys Herb (Herba Orostachyis Fimbriati) ..232Wanying Capsules .......................233Weikangling Capsules ................234Weishuning Granules..................235Wuji Baifeng Pills ........................236Chinese Gall (Galla Chinensis) .....237American Ginseng (Radix Panacis Quinquefolii) ....238Common Self-heal Fruit-Spike (Spica Prunellae) ........................239Xiatianwu Tablets .......................240Decumbent Corydalis Rhizome (Rhizoma Corydalis Decumbentis) ..............................241Xiangsha Liujun Pills ..................242

II

Xiangsha Yangwei Pills ..............243Xiangsha Zhizhu Pills .................244Dahurian Rhododendron Syrup ...245Xiaomi Suppositories .................246Xiaoshuan Tongluo Capsules ....247Xiaoshuan Tongluo Tablets .......248Xiaoyin Tablets............................249Xiaochaihu Granules ..................250Xiaochaihu Tablets .....................251Xiaoer Baibu Zhike Syrup .........252Xiaoer Huashi Pills ....................253Xiaoer Kechuan Granules .........254Xiaoer Qingre Tablets ................255Xiaoer Qingre Zhike Mixture ....256Xiaojianzhong Granules .............257Xiaoqinglong Mixture .................258Xiaoqinglong Granules ...............259Xinqin Granules ..........................260Xinqingning Tablets ....................261Xintong Mixture ..........................262Xuhan Weitong Granules ...........263Paniculate Swallowwort Root (Radix et Rhizoma Cynanchi Paniculati) ...................................264Himalayan Teasel Root (Radix Dipsaci) ...........................265Xueshuan Xinmaining Capsules .......................................266Yatong Yili Pills ...........................267Yanhusuo (Rhizoma Corydalis) 268Yangxue Shengfa Jiaonang ........269Yangyin Qingfei Pills ...................270Wild Chrysanthemum Flower (Flos Chrysanthemi Indici) .......271Yinianjin Powder .........................272Yiqing Granules ...........................273Yiganning Granules .....................274Yiqi Yangxue Mixture .................275Yinhuang Mixture .......................276Yinhuang Mixture .......................277Yinqiao Jiedu Capsules ..............278Ginkgo Leaf (Folium Ginkgo) ...279Ginkgo Leaf (Folium Ginkgo) ...280Ginkgo Tablets ............................281Ginkgo Tablets ............................282Ginkgo Biloba Leaf Extract (Extractum Folium Ginkgo Siccus) ............................283Ginkgo Biloba Leaf Extract (Extractum Folium Ginkgo Siccus) ............................284Poppy Capsule (Pericarpium Papaveris) ............285

Yupingfeng Mixture ....................286Yueju Pills ....................................287Zaizao Shengxue Tablets ...........288Zangliang Pills .............................289Thunberg Fritillary Bulb (Bulbus Fritillariae Thunbergii).... 290Zhenkening Syrup .......................291Zhennaoning Capsules ...............292Zhenggu Tincture ........................293Zhibai Dihuang Pills ...................294Zhibai Dihuang Pills ...................295Common Anemarrhena Rhizome (Rhizoma Anemarrhenae) .........296Zhizi Jinhua Pills .........................297Zhimaikang Capsules .................298Zhike Juhong Mixture ................299Immature Orange Fruit (Fructus Aurantii Immaturus)...300Zhitong Huazheng Capsules ......301Prepared Fleeceflower Root (Radix Polygoni Multiflori Praeparata) ..................................302Glabrous Sarcandra Tablets ......303Zhonghua Dieda Pills .................304Zhongfeng Huichun Pills ............305Shuanghuanglian Injection ........306Shuanghuanglian Injection ........307Shuanghuanglian Injection ........308Zhuanggu Shenjin Capsules.......309Tatarian Aster Root (Radix et Rhizoma Asteris) .......310Zuojin Pills ...................................311Amoxicillin ..................................315Amoxicillin Capsules..................316Amoxicillin and Clavulanate Potassium Tablets .......................317Amoxicillin and Clavulanate Potassium Tablets .......................318Amoxicillin Sodium ....................319Amoxicillin Tablets .....................320Aspirin Enteric-micro encapsulated Capsules ...............321Aspirin Enteric-Microe encapsulated Capsules ...............322Aspirin Effervescent Tablets .....323Aspirin Effervescent Tablets .....324Sodium Ferulate..........................325Aciclovir .......................................326Aciclovir Eye Drops ...................327Aciclovir Eye Drops ...................328Aciclovir Capsules ......................329Aciclovir Chewable Tablets .......330Aciclovir Chewable Tablets2 .....331

Aciclovir Granules ......................332Aciclovir Granule ........................333Aciclovir Tablets .........................334Aciclovir Tablets .........................335Aciclovir Ointment .....................336Aciclovir Ointment .....................337Estazolam ....................................338Estazolam Tablets .......................339Metamizole Sodium Nasal drops ..................................340Ampicillin.....................................341Ampicillin Sodium ......................342Amrinone .....................................343Omeprazole Enteric-coated Capsules .......................................344Omeprazole Enteric-coated Tablets ..........................................345Oxaprozin ....................................346Oxaprozin Enteric-coated Capsules .......................................347Oxaprozin Enteric-coated Tablets ..........................................348Betamethasone ..........................349Betamethasone Sodium Phosphate ....................................350Betamethasone Sodium Phosphate Injection....................351Betamethasone Tablets ..............352Betamethasone Ointment ......................................353Oxacillin SodiumPiracetam .....................................355Piracetam Capsules ....................356Piracetam Oral Solution.............357Piracetam and Sodium Chloride Injection .......................358Piracetam Tablets .......................359Piracetam Injection ....................360Piracetam Injection ....................361Testosterone Propionate ............362Clobetasol Propionate................363Clobetasol Propionate Cream ...364Ibuprofen Drops..........................365Ibuprofen Oral Solution .............366Ibuprofen Syrup ..........................367Bulleyaconitine A........................369Bulleyaconitine A Oral Solution ........................................370Potassium Dehydroandro grapolide Succinate ....................371Estradiol.......................................372Estradiol Sustained-release Patch .............................................373

III

Dexamethasone Acetate ............374Dexamethasone Acetate Tablets ..........................................375Dexamethasone Acetate Ointment ......................................376Megestrol Acetate Tablets .........377Hydrocortisone Acetate .............379Digoxin .........................................381Digoxin Tablets ...........................382Dexamethasone Tablets .............383Dexamethasone ..........................384Dexamethasone Sodium Phosphate Eye Drops .................386Dexamethasone Sodium Phosphate Injection....................387Diazepam .....................................388Scopolamine Butylbromide Injection .......................................389Paracetamol Drops .....................390Paracetamol Drops .....................391Paracetamol Chewable Tablets ..........................................392Paracetamol Granules ................393Paracetamol Effervescent Tablets ..........................................394Paracetamol Effervescent Tablets ..........................................395Famciclovir .................................396Famciclovir Capsules .................397Famciclovir Tablets ....................398Felodipine ....................................399Felodipine Tablets ......................400Fluconazole Tablets....................402Fluconazole and Sodium Chloride Injection .......................403Fleroxacin ....................................404Fleroxacin Capsules ...................405Fleroxacin Tablets ......................406Coenzyme Q

10 Capsules .............407

Coenzyme Q10

Capsules .............408Compound Diphenoxylate Tablets - Diphenoxylate .............409Compound Diphenoxylate Tablets - Atropine .......................410Compound Dexamethasone Acetate Cream .............................411Compound Glycyrrhiza Oral Solution ........................................412Compound Glycyrrhiza Oral Solution ........................................413Compound Glycyrrhiza Tablets ...414Glycerol and Fructose Injection .......................................418

Glipizide .......................................419Glipizide Capsules ......................420Glipizide Capsules ......................421Glipizide Tablets .........................422Puerarin .......................................423Puerarin and Sodium Chloride Injection .......................424Puerarin and Sodium Chloride Injection .......................425Puerarin and Glucose Injection 426Puerarin and Glucose Injection 427Puerarin Injection .......................428Puerarin Injection .......................429Ganciclovir ..................................430Ganciclovir and Sodium Chloride Injection .......................431Ganciclovir and Sodium Chloride Injection .......................432Halcinonide .................................433Halcinonide Membrane ..............434Erythromycin ..............................435Erythromycin Enteric-coated Tablets ..........................................436Cyclosporine Oral Solution .......437Inosine ..........................................438Inosine Capsules .........................439Inosine Oral Solution .................440Inosine Tablets ............................441Inosine Injection .........................442Inosine Injection .........................443Kitasamycin .................................444Diethylstibestrol Injection .........445Tolbutamide .................................446Mefenamic Acid ..........................447Pefloxacin Mesylate Dihydrate .448Pefloxacin Mesylate Capsules ...449Pefloxacin Mesylate Tablets ......450Pefloxacin Mesylate Injection ...451Metronidazole Capsules .............453Metronidazole Tablets ................454Metronidazole and Glucose Injection .......................................455Metronidazole Suppositories ....456Metronidazole Vaginal Effervescent Tablets ...................457Metronidazole Injection .............458Vinorelbine Tartrate ...................459Vinorelbine Tartrate Injection .......................................460Codeine Phosphate and Platycodon Tablets .....................461Clarithromycin ............................462Clarithromycin Capsules ...........463

Clarithromycin Capsules ...........464Clarithromycin Granules ...........465Clarithromycin Tablets ..............466Clarithromycin Tablets ..............467Clotrimazole Oral Pellices .........468Clotrimazole Solution ................469Clotrimazole Ointment ...............470Clotrimazole Pellicles ................471Ribavirin.......................................472Ribavirin Nasal Drops ................473Ribavirin Eye Drops ...................474Ribavirin Buccal Tablets ............475Ribavirin Capsules ......................476Ribavirin Granules ......................477Ribavirin and Sodium Chloride Injection.........478Ribavirin and Sodium Chloride Injection.........479Ribavirin Tablets .........................480Ribavirin and Glucose Injection .......................................481Ribavirin and Glucose Injection ......................................482Ribavirin Injection ......................483Ribavirin Injection ......................484Rifampicin ...................................485Rifampicin Capsules ...................486Rifampicin Capsules ...................487Benproperine Phosphate Granules .......................................488Benproperine Phosphate Oral Solution ...............................489Ligustrazine Phosphate ..............490Vindesine Sulfate ........................491Gentamycin Sulfate ....................492Salbutamol Sulfate Sustained-release Capsules .......493Micronomicin Sulfate Injection ...........................................494Etimicin Sulfate ..........................495Etimicin Sulfate Injection ..........496Azathioprine ................................497Chloramphenicol ........................498Chloramphenicol Ear Drops .....499Chloramphenicol Ear Drops .....500Chloramphenicol Eye Drops .....501Chloramphenicol Eye Drops .....502Chloramphenicol Capsules........503Chloramphenicol Tablets ...........504Chloramphenicol Eye Ointment ......................................505Cloxacillin Sodium .....................506Roxithromycin ............................507

IV

Roxithromycin Dispersible Tablets ..........................................508Roxithromycin Dispersible Tablets ..............................................509Roxithromycin for Suspension ...510Roxithromycin Capsules............511Roxithromycin Granules............512Roxithromycin Tablets ...............513Enalapril Maleate ........................514Enalapril Maleate Capsules .......515Enalapril Maleate Capsules .......516Enalapril Maleate Tablets ..........517Enalapril Maleate Tablets ..........518Moclobemide ...............................519Meleumycin .................................520Meleumycin Tablets....................521Meropenem ..................................522Meloxicam ...................................523Compound Miconazole Nitrate Cream ...........................................524Naproxen and Codeine Phosphate Tablets ......................525Naproxen .....................................526Naproxen Capsules ....................527Naproxen Granules ....................528Naproxen Tablets........................529Naproxen Suppositories ............530Nimodipine ..................................531Nimodipine Dispersible Tablets ... 532Nimodipine Dispersible Tablets ...533Nimodipine Capsules .................534Nimodipine Capsules .................535Nimodipine Tablets ....................536Nimodipine Tablets ....................537Nimodipine Injection..................538Nimodipine Injection..................539Nitrendipine Tablets ...................540Pantoprazole Sodium .................541Prednisone ...................................542Probucol.......................................543Probucol Tablets .........................544Alprostadil ...................................545Phenoxymethylpenicillin Potassium ....................................546Phenoxymethylpenicillin Potassium Tablets .......................547Phenoxymethylpenicillin Potassium Tablets .......................548Benzylpenicillin Potassium .......549Benzylpenicillin Sodium ............550Hydrocortisone ...........................551Triamcinolone Acetonide and Econazole Nitrate Cream ...552

Ethinylestradiol Tablets .............553Norethisterone ............................554Norethisterone Tablets ..............555Adenosine Disodium Triphosphate ...............................556Adenosine Disodium Triphosphate Injection ..............557Triazolam Tablets........................558Testosterone Undecanoate Soft Capsules ...............................559Huperzine-A .................................560Huperzine A Capsules ................561Huperzine A Tablets ...................562Huperzine A Tablets ...................563Huperzine A Injection ................564Sparfloxacin.................................565Sparfloxacin Capsules ................566Sparfloxacin Tablets ...................567Tinidazole ....................................568Tinidazole Capsules ....................569Tinidazole Tablets .......................570Tinidazole and Glucose Injection .......................................571Tinidazole and Glucose Injection .......................................572Tinidazole Suppositories ...........573Tinidazole Injection ....................574Tinidazole Injection ....................575Cefalexin ......................................576Cefalexin Tablets ........................577Cefalexin Tablets ........................578Cefdinir ........................................579Cefdinir ........................................580Cefdinir Capsules........................581Cefuroxime Sodium....................582Cefuroxime Axetil Capsules ......583Cefuroxime Axetil Capsules ......584Cefuroxime Axetil Tablets .........585Cefuroxime Axetil Tablets .........586Cefaclor ........................................587Cefaclor for Suspension.............588Cefaclor Capsules .......................589Cefaclor Tablets ..........................590Cefradine .....................................591Cefradine Capsules .....................592Cefathiamidine ............................593Cefoperazone ..............................594Cefoperazone Sodium ................595Cefadroxil ....................................596Cefadroxil Capsules ...................597Cefadroxil Granules ...................598Ceftriaxone Sodium....................599Ceftezole Sodium ........................600

Cefazolin Sodium ........................601Sultamicillin Tosilate Capsules .......................................602Tretinoin Cream ..........................603Vitamin B6 ...................................604Vitamin B6 Tablets ......................605Vitamin B6 Tablets ......................606Vitamin B6 Injection ...................607Vitamin B6 Injection ...................608Ubenimex.....................................609Ubenimex Capsules ....................610Raceanisodamine Tablets ..........611Nitroglycerin Aerosol .................612Miconazole Nitrate Liniment .....613Calcium Folinate .........................614Calcium Folinate Tablets ...........615Calcium Folinate Tablets ...........616Ambroxol Hydrochloride ...........617Ambroxol Hydrochloride Sustained Release Capsules ......618Ambroxol Hydrochloride Sustained Release Capsules ......619Ambroxol Hydrochloride Oral Solution ...............................620Ambroxol Hydrochloride Tablets ..........................................621Ambroxol Hydrochloride Tablets ..........................................622Ondansetron Hydrochloride......623Ondansetron Hydrochloride Tablets ..........................................624Ondansetron Hydrochloride Tablets ..........................................625Ondansetron Hydrochloride Injection .......................................626Ondansetron Hydrochloride Injection .......................................627Diphenhydramine Hydrochloride Tablets................628Diphenhydramine Hydrochloride Injection .............629Metformin Hydrochloride ..........630Metformin Hydrochloride Tablets ..........................................631Valacyclovir Hydrochloride .......632Valacyclovir Hydrochloride Capsules .......................................633Valacyclovir Hydrochloride Tablets ..........................................634Flunarizine Hydrochloride ........635Flunarizine Hydrochloride Capsules .......................................636Granisetron Hydrochloride .......637

V

Granisetron Hydrochloride Tablets ..........................................638Granisetron Hydrochloride Injection .......................................639Ciprofloxacin Hydrochloride ....640Clonidine Hydrochloride Tabelts ..........................................641Ranitidine Hydrochloride ..........642Minocycline Hydrochloride .......643Minocycline Hydrochloride Capsules .......................................644Minocycline Hydrochloride Capsules .......................................645Naphazoline Hydrochloride Nasal Drops .................................646Nicardipine Hydrochloride Injection .......................................647Nicardipine Hydrochloride Injection .......................................648Paroxetine Hydrochloride Tablets ..........................................649Tramadol Hydrochloride............650Tramadol Hydrochloride Sustained-release Capsules .......651Tramadol Hydrochloride Sustained release Capsules .......652Tramadol Hydrochloride Sustained-release Tablets ..........653Tramadol Hydrochloride Sustained-release Tablets ..........654Tramadol Hydrochloride Tablets ..........................................655Tramadol Hydrochloride Tablets ..........................................656Tramadol Hydrochloride Suppositories...............................657Tramadol Hydrochloride Suppositories...............................658Tramadol Hydrochloride Injection .......................................659Tramadol Hydrochloride Injection .......................................660Norvancomycin Hydrochloride .............................661Ticlopidine Hydrochloride .........662Ticlopidine Hydrochloride Tablets ..........................................663Oxytetracycline Hydrochloride .............................664Pseudoephedrine Hydrochloride ............................665Ofloxacin ......................................666Ofloxacin Ear Drops ...................667

Ofloxacin Eye Drops ..................668Ofloxacin Capsules .....................669Ofloxcin and Sodium Chloride Injection .......................670Ofloxcin and Sodium Chloride Injection .......................671Ofloxcin Tablets ..........................672Ofloxacin Tablets ........................673Ofloxacin Eye Ointment.............674Enoxacin ......................................675Enoxacin Eye Drops...................676Enoxacin Capsules .....................677Enoxacin Tablets ........................678Etoposide .....................................679Etoposide Injection ....................680Indometacin.................................681Indometacin Capsules ................682Indometacin Capsules ................683Indometacin Suppositories........684Indometacin Suppositories........685Amoxicillin Sodium and Clavulanate Potassium for Injection .......................................686Amoxicillin Sodium and Clavulanate Potassium for Injection .......................................687Amoxicillin Sodium for Injection .......................................688Aciclovir for Injection ................689Aciclovir for Injection ................690Ampicillin Sodium for Injection .......................................691Ampicillin Sodium for Injection .......................................692Ampicillin Sodium and Sulbactam Sodium for Injection .......................................693Ampicillin Sodium and Sulbactam Sodium for Injection...................694Oxacillin Sodium for Injection ....695Oxacillin Sodium for Injection ....696Benzathine Benzylpenicillin for Injection .................................697Potassium Dehydroandro grapolide Succinate for Injection .......................................698Potassium Dehydroandro grapolide Succinate for Injection .......................................699Ganciclovir for Injection ............700Pefloxacin Mesylate for Injection .................................701Ribavirin for Injection ................702

Vindesine Sulfate for Injection ....703Vindesine Sulfate for Injection ....704Etimicin Sulfate for Injection ....705Cloxacillin Sodium for Injection .................................706Cloxacillin Sodium for Injection ................................707Meropenem for Injection ...........708Meropenem for Injection ...........709Alprostadil for Injection.............710Benzylpenicillin Potassium for Injection .................................711Benzylpenicillin Sodium for Injection .................................712Adenosine Disodium Triphosphate for Injection .........713Cefradine for Injection ...............714Cefathiamidine for Injection .....715Cefoperazone Sodium for Injection .................................716Cefoperazone Sodium for Injection .................................717Cefoperazone Sodium and Sulbactam Sodium for Injection .................................718Cefoperazone Sodium and Sulbactam Sodium for Injection .................................719Cefazolin Sodium for Injection .................................720Calcium Folinate for Injection .................................721Calcium Folinate for Injection .................................722Norvancomycin Hydrochloride for Injection.......723Norvancomycin Hydrochloride for Injection.......724

VI

Traditional Chinese Medicine

Japanese Ardisia Herb (Herba Ardisiae Japonicae) -

Sample sourceCommercially available Japanese Ardisia Herb

Chemical reference substancesBergenin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number1532-200202)

Preparation of test solutionAccurately weigh 0.1 g of the fine powder in a conical flask. Accura-tely add 10 mL of methanol, weigh, treat ultrasonically for 40 minutes, allow to cool, weigh again, reple-nish the lost weight with metha-nol, mix well and filter.

Sample sourceCommercially available Japanese Ardisia Herb

Chemical reference substancesBergenin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number1532-200202)

Preparation of test solutionAccurately weigh 0.1 g of the fine powder in a conical flask. Accura-tely add 10 mL of methanol, weigh, treat ultrasonically for 40 minutes, allow to cool, weigh again, reple-nish the lost weight with metha-nol, mix well and filter.

Chromatographic conditionsColumn: ZORBAX SB C18 4.6150 mm, 5 m (883975-902)

Column temperature: 35 C

Mobile phase: methanol-water (20:80)

Detector wavelength: 275 nm

Flow rate: 1.0 mL/min

Injection volume: 2 L







Chromatographic systemAgilent 1200 Series quaternary pump with vacuum degasser

Agilent 1200 Series high-perfor-mance autosampler

Agilent 1200 Series thermostat-ted column compartment

Agilent 1200 Series variable wavelength detector

System control through Agilent ChemStation revision B.01.01






Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfBergenin .599 5.518 2.65 227.6 7784 1.04Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfBergenin .599 5.518 2.65 227.6 7784 1.04

4

Aifu Nuangong Pills (Aifu Nuangong Wan) -

Sample sourceCommercially available Aifu Nuan-gong Pills

Chemical reference substancesPaeoniflorin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number0736-200220)

Preparation of test solutionCut the pills into pieces. Accu-rately weigh 0.8 g in a stoppered conical flask, accurately add 10 mL of 50 % methanol, stopper well, and weigh. Treat ultrasonically for 40 minutes, allow to cool, weigh again, replenish the lost weight with 50 % methanol, shake well, filter through a millipore membra-ne (0.45 m) and use the filtrate as the test solution.

Sample sourceCommercially available Aifu Nuan-gong Pills


Preparation of test solutionCut the pills into pieces. Accu-rately weigh 0.8 g in a stoppered conical flask, accurately add 10 mL of 50 % methanol, stopper well, and weigh. Treat ultrasonically for 40 minutes, allow to cool, weigh again, replenish the lost weight with 50 % methanol, shake well, filter through a millipore membra-ne (0.45 m) and use the filtrate as the test solution.



Mobile phase: acetonitrile-0.1 % phosphoric acid (12:88)


















min0 2 4 6 8 10 12 14 16

mAU

0

20

40

60

80

3.821

4.237 4.841

5.240

9.424

11.913

Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfPaeoniflorin 8.928 11.91 9.20 715.5 10274 0.99

5

Anshen Buxin Pills (Anshen Buxin Wan) -

Sample sourceCommercially available Anshen Buxin Pills

Chemical reference substancesSchisandrin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110857-200203)

Preparation of test solutionAccurately weigh 15 pills, grind to a fine powder and mix well. Accurately weigh 0.5 g, accurately add 25 mL of methanol, weigh, treat ultrasonically for 30 minutes, allow to reach room temperature, weigh again and replenish the lost weight with methanol. Mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Anshen Buxin Pills


Preparation of test solutionAccurately weigh 15 pills, grind to a fine powder and mix well. Accurately weigh 0.5 g, accurately add 25 mL of methanol, weigh, treat ultrasonically for 30 minutes, allow to reach room temperature, weigh again and replenish the lost weight with methanol. Mix well, filter and use the filtrate as the test solution.





















Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfSchisandrin 11.087 0.218 4.76 165.0 17750 1.02Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfSchisandrin 11.087 0.218 4.76 165.0 17750 1.02

6

Anshen Capsules (Anshen Jiaonang) -

Sample sourceCommercially available Anshen Capsules


Preparation of test solutionGrind the content of the capsules to a fine powder and mix well. Accurately weigh 1.0 g of the pow-der in a stoppered conical flask. Accurately add 25 mL of a mixture of chloroform and methanol (2:1), weigh, treat ultrasonically for 40 minutes, allow to cool, weigh again, replenish the lost weight with the mixture of chloroform and methanol (2:1), mix well and filter, use the filtrate as the test solution.

Sample sourceCommercially available Anshen Capsules


Preparation of test solutionGrind the content of the capsules to a fine powder and mix well. Accurately weigh 1.0 g of the pow-der in a stoppered conical flask. Accurately add 25 mL of a mixture of chloroform and methanol (2:1), weigh, treat ultrasonically for 40 minutes, allow to cool, weigh again, replenish the lost weight with the mixture of chloroform and methanol (2:1), mix well and filter, use the filtrate as the test solution.























Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfSchisandrin 5.424 16.059 8.89 201.6 11701 0.98Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfSchisandrin 5.424 16.059 8.89 201.6 11701 0.98

7

Anzhong Tablets (Anzhong Pian) -

Sample sourceCommercially available Anzhong Tablets

Chemical reference substancesAmmonium glycyrrhizinate (Na-tional Institute for the Control of Pharmaceutical and Biological Products, Batch number0731-9704)

Preparation of test solutionAccurately weigh 20 tablets or film-coated tablets with coating removed, grind well, accurately weigh 1 g in a stoppered conical flask, accurately add 10 mL of the mobile phase, stopper tightly and weigh. Treat ultrasonically for 30 minutes, allow to cool, weigh again, replenish the lost weight with the mobile phase, and shake well. Filter through a millipore membrane (0.45 m) and use the filtrate as the test solution.

Sample sourceCommercially available Anzhong Tablets

Chemical reference substancesAmmonium glycyrrhizinate (Na-tional Institute for the Control of Pharmaceutical and Biological Products, Batch number0731-9704)

Preparation of test solutionAccurately weigh 20 tablets or film-coated tablets with coating removed, grind well, accurately weigh 1 g in a stoppered conical flask, accurately add 10 mL of the mobile phase, stopper tightly and weigh. Treat ultrasonically for 30 minutes, allow to cool, weigh again, replenish the lost weight with the mobile phase, and shake well. Filter through a millipore membrane (0.45 m) and use the filtrate as the test solution.



Mobile phase: methanol-0.2mol/L ammonium acetate-glacial acetic acid (68:32:1)





Mobile phase: methanol-0.2mol/L ammonium acetate-glacial acetic acid (68:32:1)













Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfGlycyrrhizinic acid 2.204 .845 89.95 815. 415 1.00Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfGlycyrrhizinic acid 2.204 .845 89.95 815. 415 1.00

8

Bazhen Yimu Pills (Bazhen Yimu Wan) -

Sample sourceCommercially available Bazhen Yimu pills


Preparation of test solutionCut a quantity of the pills into pieces and mix well, take 0.2 g of the pieces and accurately weigh in a stoppered conical flask. Accura-tely add 10 mL of dilute ethanol, stopper well, weigh and treat ultra-sonically for 40 minutes. Allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix thorough-ly, centrifuge and use the superna-tant liquid as the test solution.

Sample sourceCommercially available Bazhen Yimu pills


Preparation of test solutionCut a quantity of the pills into pieces and mix well, take 0.2 g of the pieces and accurately weigh in a stoppered conical flask. Accura-tely add 10 mL of dilute ethanol, stopper well, weigh and treat ultra-sonically for 40 minutes. Allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix thorough-ly, centrifuge and use the superna-tant liquid as the test solution.



Mobile phase: acetonitrile-0.1 % phosphoric acid solution (13:87)





Mobile phase: acetonitrile-0.1 % phosphoric acid solution (13:87)













min0 2 4 6 8 10 12 14 16

mAU

0

5

10

15

20

25

30

4.940 7.819

9.739

Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfPaeoniflorin 7.116 9.79 1.46 198. 10099 1.00

9

Bazheng Mixture (Bazheng Heji) -

Sample sourceCommercially available Bazheng Heji

Chemical reference substancesGeniposide (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110749-200309)

Preparation of test solutionAccurately measure 5 mL of the mixture in a 50 mL volumetric flask, dilute to volume with dilute ethanol and mix well, centrifuge and use the supernatant liquid as the test solution.

Sample sourceCommercially available Bazheng Heji


Preparation of test solutionAccurately measure 5 mL of the mixture in a 50 mL volumetric flask, dilute to volume with dilute ethanol and mix well, centrifuge and use the supernatant liquid as the test solution.

Chromatographic conditionsColumn: ZORBAX XDB C18 4.6150 mm, 5 m (993967-902)


Mobile phase: acetonitrile-water (10:90)













Agilent 1200 Series diode-array detector







Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfGeniposide 6.44 11.016 6.14 1120.6 9221 1.05Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfGeniposide 6.44 11.016 6.14 1120.6 9221 1.05

10

Chinaroot Greenbrier Rhitome (Rhizoma Smilacis Chinae) -

Sample sourceCommercially available Chinaroot Greenbrier Rhizome

Chemical reference substancesDiosgenin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number1539-200201)

Preparation of test solutionAccurately weigh 8 g of the pow-der into a Soxhlet extractor (No. 2 sieve), add a quantity of ethanol, and soak overnight, heat under reflux until the extract is colorless. Recover the solvent to about 100 mL, add 16 mL of hydrochloric acid, heat under reflux on a water bath for 2 hours, allow to cool, and extract with four 40 mL quantities of petroleum ether (60-90 C) by shaking. Combine the extracts, evaporate the solvent to dryness. Dissolve the residue in acetonitrile and transfer to a 10 mL volumetric flask, dilute with acetonitrile to volume, mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Chinaroot Greenbrier Rhizome

Chemical reference substancesDiosgenin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number1539-200201)

Preparation of test solutionAccurately weigh 8 g of the pow-der into a Soxhlet extractor (No. 2 sieve), add a quantity of ethanol, and soak overnight, heat under reflux until the extract is colorless. Recover the solvent to about 100 mL, add 16 mL of hydrochloric acid, heat under reflux on a water bath for 2 hours, allow to cool, and extract with four 40 mL quantities of petroleum ether (60-90 C) by shaking. Combine the extracts, evaporate the solvent to dryness. Dissolve the residue in acetonitrile and transfer to a 10 mL volumetric flask, dilute with acetonitrile to volume, mix well, filter and use the filtrate as the test solution.

Chromatographic conditionsColumn: ZORBAX XDB C18, 4.6250 mm,5 m (990967-902)




Flow rate: 1.0 mLmin


Chromatographic conditionsColumn: ZORBAX XDB C18, 4.6250 mm,5 m (990967-902)




Flow rate: 1.0 mLmin












Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfDiosgenin 1.607 6.517 5.20 24.4 21754 1.05Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfDiosgenin 1.607 6.517 5.20 24.4 21754 1.05

11

Baidai Pills (Baidai Wan) -

Sample sourceCommercially available Baidai Wan

Chemical reference substancesBerberine hydrochloride (National Institute for the Control of Phar-maceutical and Biological Pro-ducts, Batch number110713-200209)

Preparation of test solutionGrind a quantity of the pills to a fine powder and mix well. Accu-rately weigh about 0.2 g of the powder, accurately add 25 mL of a mixture of methanol and hydro-chloric acid (1:100), weigh, heat under reflux for 30 minutes, allow to cool to room temperature, weigh again and replenish the lost weight with a mixture of methanol and hydrochloric acid (1:100). Mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Baidai Wan

Chemical reference substancesBerberine hydrochloride (National Institute for the Control of Phar-maceutical and Biological Pro-ducts, Batch number110713-200209)

Preparation of test solutionGrind a quantity of the pills to a fine powder and mix well. Accu-rately weigh about 0.2 g of the powder, accurately add 25 mL of a mixture of methanol and hydro-chloric acid (1:100), weigh, heat under reflux for 30 minutes, allow to cool to room temperature, weigh again and replenish the lost weight with a mixture of methanol and hydrochloric acid (1:100). Mix well, filter and use the filtrate as the test solution.



Mobile phase: acetonitrile-0.05mol/L potassium dihydrogen phosphate solution (adjust to pH 5.05 with sodium hydroxide TS) (25:75)




Mobile phase: acetonitrile-0.05mol/L potassium dihydrogen phosphate solution (adjust to pH 5.05 with sodium hydroxide TS) (25:75)












Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfBerberine 5.886 10. 25.17 70. 11860 1.10Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfBerberine 5.886 10. 25.17 70. 11860 1.10

12

White Peony Root (Radix Paeoniae) -

Sample sourceCommercially available White Peony Root (Zhejiang)


Preparation of test solutionAccurately weigh 0.1 g of the powder in a 50 mL volumetric flask, add 35 mL of diluted ethanol, treat ultrasonically for 30 minu-tes, allow to cool and dilute with dilute ethanol to volume, mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available White Peony Root (Zhejiang)


Preparation of test solutionAccurately weigh 0.1 g of the powder in a 50 mL volumetric flask, add 35 mL of diluted ethanol, treat ultrasonically for 30 minu-tes, allow to cool and dilute with dilute ethanol to volume, mix well, filter and use the filtrate as the test solution.





















Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP Tf

Paeoniflorin 8.007 5.12 507.6 7126 0.96


Paeoniflorin 8.007 5.12 507.6 7126 0.96

min0 2 4 6 8 10

mAU

0

10

20

30

40

50

8.007

1

Dahurian Angelica Root (Radix Angelicae Dahuricae) -

Sample sourceCommercially available Dahurian Angelica Root

Chemical reference substancesImperatorin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110826-200307)

Preparation of test solutionAccurately weigh 0.2 g of the pow-der in a 25 mL volumetric flask, add 45 mL of methanol, treat ultra-sonically for 60 minutes, allow to cool and dilute with methanol to volume, and mix well.

Sample sourceCommercially available Dahurian Angelica Root

Chemical reference substancesImperatorin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110826-200307)

Preparation of test solutionAccurately weigh 0.2 g of the pow-der in a 25 mL volumetric flask, add 45 mL of methanol, treat ultra-sonically for 60 minutes, allow to cool and dilute with methanol to volume, and mix well.
























Imperatorin 14.88 19.058 9.22 26.2 1016 0.99


Imperatorin 14.88 19.058 9.22 26.2 1016 0.99

14

Baihe Gujin Pills (Baihe Gujin Wan) -

Sample sourceCommercially available Baihe Gujin Wan


Preparation of test solution

Cut the pills into pieces and mix well. Accurately weigh about 1 g in a stoppered co-nical flask, accurately add 10 mL of dilute ethanol, stopper well, weigh and allow to stand overnight. Treat ultrasonically for 40 minutes, allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Baihe Gujin Wan


Preparation of test solution

Cut the pills into pieces and mix well. Accurately weigh about 1 g in a stoppered co-nical flask, accurately add 10 mL of dilute ethanol, stopper well, weigh and allow to stand overnight. Treat ultrasonically for 40 minutes, allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix well, filter and use the filtrate as the test solution.























Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfPaeoniflorin 10.918 14.01 18.61 82.7 1104 1.00Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfPaeoniflorin 10.918 14.01 18.61 82.7 1104 1.00

15

Bailing Capsules (Bailing Jiaonang) -

Sample sourceCommercially available Bailing Jiaonang

Chemical reference substancesAdenosine (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110879-200202)

Preparation of test solutionAccurately weigh 0.5 g of the con-tent of the capsule in a stoppered conical flask, mix well. Accurately add 20 mL of ether, stopped tightly, soak for 30 minutes, filter and dis-card ether. Evaporate the residue to dryness. Accurately add 50 mL of 0.5 % phosphoric acid, stopper tightly, accurately weigh, treat ultrasonically for 30 minutes, cool, accurately weigh again, replenish the lost weight with 0.5 % phos-phoric acid, mix well and allow to stand. Filter the supernatant liquid through a millipore membrane (0.45 m), use the filtrate as the test solution.

Sample sourceCommercially available Bailing Jiaonang

Chemical reference substancesAdenosine (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110879-200202)

Preparation of test solutionAccurately weigh 0.5 g of the con-tent of the capsule in a stoppered conical flask, mix well. Accurately add 20 mL of ether, stopped tightly, soak for 30 minutes, filter and dis-card ether. Evaporate the residue to dryness. Accurately add 50 mL of 0.5 % phosphoric acid, stopper tightly, accurately weigh, treat ultrasonically for 30 minutes, cool, accurately weigh again, replenish the lost weight with 0.5 % phos-phoric acid, mix well and allow to stand. Filter the supernatant liquid through a millipore membrane (0.45 m), use the filtrate as the test solution.

Chromatographic conditionsColumn: ZORBAX Bonus-RP, 4.6250 mm, 5 m (880668-901)


Mobile phase: acetonitrile-40 mmol/L potassium dihydrogen phosphate (6:94)



Chromatographic conditionsColumn: ZORBAX Bonus-RP, 4.6250 mm, 5 m (880668-901)


Mobile phase: acetonitrile-40 mmol/L potassium dihydrogen phosphate (6:94)













Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfAdenosine 2.619 9.048 16.74 252.5 85 1.05Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfAdenosine 2.619 9.048 16.74 252.5 85 1.05

16

Baokening Granules (Baokening Keli) -

Sample sourceCommercially available Baokening Keli

Chemical reference substancesBaicalin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110715-200212)

Preparation of test solutionAccurately weigh 0.5 g of the granules in a stoppered conical flask, grind to a powder, accurately add 50 mL of dilute ethanol, weigh, heat under reflux for 1 hour, allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix thoroughly, allow to stand, filter the supernatant liquid, and use the filtrate as the test solution.

Sample sourceCommercially available Baokening Keli

Chemical reference substancesBaicalin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110715-200212)

Preparation of test solutionAccurately weigh 0.5 g of the granules in a stoppered conical flask, grind to a powder, accurately add 50 mL of dilute ethanol, weigh, heat under reflux for 1 hour, allow to cool to room temperature, weigh again and replenish the lost weight with dilute ethanol. Mix thoroughly, allow to stand, filter the supernatant liquid, and use the filtrate as the test solution.



Mobile phase: methanol-water-phosphoric acid (41:59:0.2)





Mobile phase: methanol-water-phosphoric acid (41:59:0.2)













Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfBaicalin 9.514 15.771 11.76 4. 7010 0.96

17

Baohe Pills (Baohe Wan) -

Sample sourceCommercially available Baohe Wan

Chemical reference substancesHesperidin (National Institute for the Control of Pharmaceutical and Biological Products, Batch number110721-200211)

Preparation of test solutionCut the pills into pieces, take about 5 g, accurately weigh, add a quantity of kieselguhr, grind well, transfer to a Soxhlet extractor, add 80 mL of petroleum ether (60-90 C), heat under reflux for 2.5 hours. Discard the petroleum ether extract and evaporate the residue to dryness, add 80 mL of methanol, heat under reflux until the extract solution is colorless, allow to cool and filter. Transfer the filtrate to a 100 volumetric flask, wash the container with a small quantity of methanol several times, filter the washings into the same flask, di-lute with methanol to volume, and mix well. Accurately transfer 5 mL to a 10 mL volumetric flask, dilute with mobile phase to volume. Mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Baohe Wan


Preparation of test solutionCut the pills into pieces, take about 5 g, accurately weigh, add a quantity of kieselguhr, grind well, transfer to a Soxhlet extractor, add 80 mL of petroleum ether (60-90 C), heat under reflux for 2.5 hours. Discard the petroleum ether extract and evaporate the residue to dryness, add 80 mL of methanol, heat under reflux until the extract solution is colorless, allow to cool and filter. Transfer the filtrate to a 100 volumetric flask, wash the container with a small quantity of methanol several times, filter the washings into the same flask, di-lute with methanol to volume, and mix well. Accurately transfer 5 mL to a 10 mL volumetric flask, dilute with mobile phase to volume. Mix well, filter and use the filtrate as the test solution.



Mobile phase: methanol-6.8 % glacial acetic acid (32:68)





Mobile phase: methanol-6.8 % glacial acetic acid (32:68)













Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfHesperidin 4.945 7.14 5.41 742.4 618 1.0Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfHesperidin 4.945 7.14 5.41 742.4 618 1.0

18

Baohe Watered Pills (Baohe Wan (Shuiwan)) -

Sample sourceCommercially available Baohe Watered Pills


Preparation of test solutionGrind a quantity of the pills to a fine powder and mix well. Accura-tely weigh about 2 g of the powder in a Soxhlet extractor, add 80 mL of petroleum ether (60-90 C), heat under reflux for 2-3 hours. Discard the petroleum ether extract and evaporate the residue to dryness, add 80 mL of methanol, heat under reflux until the extract solution is colorless, allow to cool and filter. Transfer the filtrate to a 100 mL of a volumetric flask, wash the container with a small quantity of methanol several times, filter the washings into the same flask, di-lute with methanol to volume and mix well. Accurately transfer 5 mL to a 10 mL volumetric flask, dilute with mobile phase to volume. Mix well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Baohe Watered Pills


Preparation of test solutionGrind a quantity of the pills to a fine powder and mix well. Accura-tely weigh about 2 g of the powder in a Soxhlet extractor, add 80 mL of petroleum ether (60-90 C), heat under reflux for 2-3 hours. Discard the petroleum ether extract and evaporate the residue to dryness, add 80 mL of methanol, heat under reflux until the extract solution is colorless, allow to cool and filter. Transfer the filtrate to a 100 mL of a volumetric flask, wash the container with a small quantity of methanol several times, filter the washings into the same flask, di-lute with methanol to volume and mix well. Accurately transfer 5 mL to a 10 mL volumetric flask, dilute with mobile phase to volume. Mix well, filter and use the filtrate as the test solution.



Mobile phase: methanol-glacial acetic acid-water (38:6:56)



















Hesperidin .716 68.46 61.6 861 1.00


Hesperidin .716 68.46 61.6 861 1.00

19

Baoji Pills (Baoji Wan) -

Sample sourceCommercially available Baoji Wan

Chemical reference substances1. Magnolol, 2. Honokiol (Nati-onal Institute for the Control of Pharmaceutical and Biological Products, Batch number 1.0729-200006, 2.0730-9204)

Preparation of test solutionAccurately weigh 1.0 g of the fine powder in a stoppered conical flask, add 100 mL of petroleum ether (30-60 C) and treat ultraso-nically for 30 minutes, and filter. Treat the residue ultrasonically again with 50 mL of petroleum ether (30-60 C) for 30 minutes and filter. Combine the filtrates, evaporate to dryness, dissolve the residue in methanol, transfer to a 10 mL volumetric flask, dilute to volume with methanol, shake well, filter and use the filtrate as the test solution.

Sample sourceCommercially available Baoji Wan

Chemical reference substances1. Magnolol, 2. Honokiol (Nati-onal Institute for the Control of Pharmaceutical and Biological Products, Batch number 1.0729-200006, 2.0730-9204)

Preparation of test solutionAccurately weigh 1.0 g of the fine powder in a stoppered conical flask, add 100 mL of petroleum ether (30-60 C) and treat ultraso-nically for 30 minutes, and filter. Treat the residue ultrasonically again with 50 mL of petroleum ether (30-60 C) for 30 minutes and filter. Combine the filtrates, evaporate to dryness, dissolve the residue in methanol, transfer to a 10 mL volumetric flask, dilute to volume with methanol, shake well, filter and use the filtrate as the test solution.

Chromatographic conditionsColumn: ZORBAX SB C18, 4.6250 mm, 5 m (880975-902)





Chromatographic conditionsColumn: ZORBAX SB C18, 4.6250 mm, 5 m (880975-902)















Components k Ret Time (min) Height (mAU) Area (mAU*s) n USP TfHonokiol 1.910 7.274 5.87 29.9 18660 1.02 Magnolol .059 10.148 1.71 51.9 20001 0.95

20

Biyan Tablets (Biyan Pian) -

Sample sourceCommercially available Biyan Tablets

Chemical reference substancesMagnolin (National Institute for the Control of Pharmaceutical and Biological Products, Batch num-ber: 110882-200203)

Preparation of test solutionAccurately weigh 10 tablets, remove the coating, grind to a fine powder. accurately weigh 0.4 g, in a stoppered conical flask, accurately add 10 mL of methanol, stopper tightly and weigh. Treat ul-trasonically for 30 minutes, allow to cool, weigh again and replenish the lost weight with methanol, mix well and filter. Accurately measu-re 5 mL of the successive filtrate and apply to a neutral alumina column (100-200 mesh, 10 mm in internal diameter, packed with 2 g of neutral alumina by methanol, washed previously with metha-nol) and elute with a quantity of methanol, collect eluent in a 10 mL volumetric flask until almost to the volume, dilute with methanol to volume and mix well. Filter and use the filtrate as the test solution.

Sample sourceCommercially available Biyan Tablets

Chemical reference substancesMagnolin (National Institute for the Control of Pharmaceutical and Biological Products, Batch num-ber: 110882-200203)

Preparation of test solutionAccurately weigh 10 tablets, remove the coating, grind to a fine powder. accurately weigh 0.4 g, in a stoppered conical flask, accurately add 10 mL of methanol, stopper tightly and weigh. Treat ul-trasonically for 30 minutes, allow to cool, weigh again and replenish the lost weight with methanol, mix well and filter. Accurately measu-re 5 mL of the successive filtrate and apply to a neutral alumina column (100-200 mesh, 10 mm in internal diameter, packed with 2 g of neutral alumina by methanol, washed previously with metha-nol) and elute with a quantity of methanol, collect eluent in a 10 mL volumetric flask until almost to the volume, dilute with methanol to volume and mix well. Filter and use the filtrate as the test solution.
























Hesperidin .716 68.46 61.6 861 1.00


Hesperidin .716 68.46 61.6 861 1.00

21

Biyuanshu Mixture (Biyuanshu Koufuye) -

Sample sourceCommercially available Biyuanshu Mixture


Preparation of test solutionAccurately measure 0.1 mL of the mixture in a 10 mL volumetric flask, dilute with 50 % methanol to volume and shake thoroughly, fil-ter through a millipore membrane (0.45 m), filter and use the filtrate as the test solution.

Sample sourceCommercially available Biyuanshu Mixture


Preparation of test solutionAccurately measure 0.1 mL of the mixture in a 10 mL volumetric flask, dilute with 50 % methanol to volume and shake thoroughly, fil-ter through a millipore membrane (0.45 m), filter and use the filtrate as the test solution.



Mobile phase: methanol-0.2 %phosphoric acid solution (30:70)





Mobile phase: methanol-0.2 %phosphoric acid solution (30:70)



Chromatographic systemAgilent 1200 Series quate

Documents

Compendium of HPLC Applications for Traditional Chinese