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 Journal of Chromatography A, 1323 (2014) 87–96 Contents lists available at ScienceDirect  Journalof ChromatographyA  j ournal home pag e : www.elsevier.com/locate/chroma Theselectionof suitablecolumnsforareversed-phaseliquid chromatographicseparationof beta-lactamantibioticsandrelated substancesviachromatographiccolumnparameters Wei-qingZhang 1 ,Qiu-xinHu 1 ,XiaZhang,Ya-pingLi,Ming-juanWang,Chang-qinHu Nat ional Ins tit ute s for Foo d and Drug Control, Bei ji ng 100050, China art icleinfo  Article history: Received 4 June 2013 Rec eived in rev ise d for m 31 Oct obe r 2013 Acc ept ed 1 November 2013 Available online 11 November 2013 Keywords: Column parameter -Lacta m antib iotic Cri tic al pea k pai r Selection of chromatogr aphic column abstract Theselectionof RP-LCcolumnssuitablefora par ticularanalysisin of cialcompendiais di f cult as onlyageneraldescriptionof thestationaryphaseinthedescriptionof aLC methodisgiven.General methodstocharacterizeRP-LCcolumnsoftenassumethateachof thecolumnparametersisequally important. Thiscancausetheusertoselectcolumnsinappropriateforparticularanalyses.Thispaper focusesontherelationshipbetweenthecriticalpeakpairsandthecolumnparameters(H ,S , A,B,and C )intheSnyder/Dolancolumncharacterizationmethodologytondthekeyparametersinuencing realseparations.Somevarietiesof -lactamantibioticsand theirrelatedcompoundswereusedastest compounds.Wefoundcolumnparameter A tobethemostimportantfactoraffectingtheirseparation. ParametersB and C alsoplayedanimportantroleinsomeseparationprocesses.This indica tedthatthe hydrogenbondingof columnandsolutecandirectlyaffecttheseparationof -lactamantibiotics.Choos- ingcolumnsforwhichcolumnparameter A isnear0.1 canfacilitatetheideal separat ions of impurities from-lactamantibiotics.Themostsuitablecolumnforanycommonpharmaceuticalanalysiscould beselectedeasilyif thekeycolumnparameterswouldbegiveninthedescriptionof thechromato- graphicmethod.Forthesereasons,keycolumnparametersshouldbelistedinthemonographsof ofcial compendia. © 2013 Elsevier B.V. All rights reserved. 1. Intr oduc tion - Lact am anti bi oti cs are wid el y us ed be ca us e of th ei rpro - n ou nc e d c li ni ca l ef f ec ti v en e ss an d l ow to xi ci ty . H ow e ve r, the beta-lac tamringis ver y unstable and ca n eas ilyundergoa var iet y of react ion s suc h as hydro lys is, mol ecu lar rearra ngement, and pol y- merization [1,2]. The key to m ai nt ai ni n g t he qua li t y of  -lactam antibiotics is the con tro l of rel ated substanc es. Cur ren tly , hig h-p erf ormance liq uid chromatogra phi c (HP LC) methods, wh ich are mainl y per formed wi th revers ed- pha se con - di ti ons (R P- LC) , ha v e be en wi d el y us ed in of ci al comp endi a, such as the European Phar ma co peia (Ph. Eur. ), the Unit ed Stat es Pharmac ope ia (USP) and the Chinese Pha rma cop eia (Ch P) . RP- LC meth ods are main ly usedto control relat ed subst ance s [3–5]. In the desc ri pt ions of th ese methods gi ven inthe compendi a, exact el u- ent compos ition and oth er exp erimental conditions are pro vid ed. Cor res pon din g aut hor at: Nat ion al Ins titutes for Food and Drug Con tro l, No. 2, Tia nta n Xil i, Don gchengDistr ict , Bei jing 100050, Chi na. Tel .: +86 010 6709530 8; fax:+86 010 6511 5148. E-mai l addres s: [email protected] (C.-q . Hu). 1 Thes e autho rs cont ribute d equal ly. Howe ve r, on ly v er y g en er a l in fo r ma ti on is g iv en ab o ut th e sta- tio nar y pha se. Thu s, reprod uci ng the chromato gr aph ic sep aratio n des cri bed in the compen dia mayfa il du e to la ck of de ta il ed in fo r- mat ion , spe cical ly the bra nd name of the sta tio nary pha ses . The re are over 80 0 bran ds of commerci al C18 columns available on the ma rket an d th ei r select iv it y is in uen ce d by ma ny fa c to rs , s uch as the pre sen ce of fre e silanol gr oup s, end -ca ppi ng and emb edd ed polargroups [6]. Newtechnolo gies,such as hybr id parti cle tech nol- ogy and polymer-c oatin g, make theseproperti es more wide sprea d. The Ph. Eur. descri bes the suit able type of th e stationa ry phas e in termsof cha in leng th, end-capping,base-deactivatio n, part iclesize, and someti mes pore siz e and speci c sur fac e are a. The USP renes the chromato gra phic column classi c ati on (L 1–L 72) accord ing to the ty pes of the co lumn packing material. However, this informa- ti on is usuall y not suf ci ent to facilitate the selection of a suitable col umn wit h the req uir ed sel ect ivi ty. This problem could be solved if a general RP-LC column ch a ra ct eri za ti on me th od co ul d be deve lo ped. Colu m ns c an be characte riz ed usi ng chromato gra phi c and non-ch romato gra phic methods [6]. Non- ch roma tographi c methods are not prac ti ca l bec aus e they are destructi ve to pac ked columns. Several research gr oups have publ ished or iginal ar ti cl es on methods of ch roma to- gra phic col umn cha rac ter iza tio n thr oug h which the proper ties of 0021-9 673/ $ seefrontmatter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.chroma.2013.11.005

Column Selection HPLC Beta-lactam Antibiotics

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