University Department of chemical technology, thesis_Certificates

8/6/2019 University Department of chemical technology, thesis_Certificates

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Development and Validation of UV and HPLC Methods for

Simultaneous Estimation of Aceclofenac and Rabeprazole Sodium

in Capsule Dosage FormThesis Submitted To

Dr. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY

In the partial fulfillment of requirement for

the award of degree of

MASTER OF TECHNOLOGY

(CHEMICAL)

DRUGS AND PHARMACEUTICALS

By

Mr. DULAL MAHAVIR MOHATOUnder the guidance of

Dr. P. S. WAKTE

Reader

ISO 9001-2008 Certified

DEPARTMENT OF CHEMICAL TECHNOLOGY,

Dr. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY,

AURANGABAD-431004.

2011


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Dr. Babasaheb Ambedkar Marathwada University,

AurangabadNAAC Accredited B+

Department of Chemical Technology

ISO 9001:2008 Certified

Faculty of Engineering & Technology

University Campus, Aurangabad.

CERTIFICATE

This is to certify that the thesis entitled Development and Validation of UV

and HPLC Methods for Simultaneous Estimation of Aceclofenac and

Rabeprazole Sodium in Capsule Dosage Formby Mr. DULAL MAHAVIR

MOHATO, was satisfactorily carried out under my overall supervision and

guidance at the Department of Chemical Technology, Dr. Babasaheb

Ambedkar Marathwada University, Aurangabad in the partial fulfillment of

the requirement for the Master of Technology (Chemical) [Drugs &

Pharmaceuticals].

Place: Aurangabad Dr. P. S. Wakte

Date: (Reader)


3/6


Aurangabad

NAAC Accredited B+





CERTIFICATE

This is to certify that the thesis entitled Development and Validation of UV

and HPLC Methods for Simultaneous Estimation of Aceclofenac and

Rabeprazole Sodium in Capsule Dosage Form is a bonafide work of Mr.

DULAL MAHAVIR MOHATO submitted to the Department of Chemical

Technology, Dr. Babasaheb Ambedkar Marathwada University,

Aurangabad in the partial fulfillment of the requirement for the Master of

Technology (Chemical) [Drugs & Pharmaceuticals].

Place:Aurangabad Dr. Devanand B. Shinde

Date: Professor and Head


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AurangabadNAAC Accredited B+





CANDIDATES DECLARATION

I submit this thesis entitled Development and Validation of UV and HPLC

Methods for Simultaneous Estimation of Aceclofenac and Rabeprazole

Sodium in Capsule Dosage form in partial fulfillment for the Master of

Technology (Chemical) [Drugs & Pharmaceuticals] to Dr. Babasaheb

Ambedkar Marathwada University, Aurangabad. I hereby declare that the

project or part thereof has not been previously submitted by me.

Place:Aurangabad. Mr. DULAL M. MOHATO

Date:


5/6

ACKNOWLEDGEMENT

I take this opportunity with much pleasure to thank all the people who

have helped me through the course of my journey towards producing this

thesis. I express my deep sense of gratitude and thanks to Dr. D. B. Shinde,

Professor & Head, Department of Chemical Technology, who provided me an

opportunity to work on HPLC project. He allowed me to use all the facilities

of the department and supported me like a pillar for constant inspiration.

It is a great pleasure and moment of satisfaction for me to express

deep sense of gratitude towards Dr. P. S. Wakte, Reader, Department of

Chemical Technology, and my project guide for his continuous

encouragement and guidance in making my project successful.

My sincere thanks to Dr. J. N. Sangshetti, Associate Professor, Y.B.

Chavan College of Pharmacy, Aurangabad for his meticulous guidance, help

and support during my project work. I would like to express my appreciation

to Mr. A. A. Patil, Mr. S. N. Darandale and Mrs. P. N. Chougule for their

valuable guidance and encouragement. I would like to express my heart-felt

thanks to my colleagues Mr. A. L. Kharat, Mr. C. R. Gadekar, Mr. M. D.

Deoraye and my Senior Mr. R. R. Ratha, Mr. S. P. Deshmukh for their

assistance, criticisms, useful insights, encouragement and compassion. I

gratefully acknowledge M/s Wockhardt Limited, Aurangabadfor providing

the gift samples of Aceclofenac and Rabeprazole Sodium for project work.

Finally, this thesis would not have been possible without the

confidence, endurance and support of my family. My family has always been

a source of inspiration and encouragement. I wish to thank my parents, Shri

M. R. Mohato and Smt. R. Devi, whose love, teachings and support have

brought me this far.

DULAL M. MOHATO


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CONTENTS

Sr. No Name of chapter Page No.

1 Introduction

Introduction to Analytical Chemistry 2 Analytical Methods 2 Analytical Development 4 Ultraviolet and Visible Spectrometry 5 High Performance Liquid Chromatography 9 Quantitation Methods 44 Regulatory Practices 45 Validation 47 Data Elements Required For Assay Validation 55

2. Objectives 59

3. Review of Literature 61

4. Materials and Methods

Working Standards and Chemicals 71 Instruments 71 Spectrophotometric Method Development and Validation 72 HPLC Method Development and Validation 76

5. Results and Discussion 82

6. Conclusion 114

7. Future Scope 115

8. References 116

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University Department of chemical technology, thesis_Certificates