Chapter 6 - Beirut Arab University

Development and Validation of Sensitive

Methods for the Analysis of Some Selected

Drugs

by

Malak Youssef Al-Bathish

Thesis

Submitted in Partial Fulfillment of the requirements for the Degree of Master in Pharmaceutical Analytical Chemistry and Drug Quality

Control

Department of Pharmaceutical Technology Faculty of Pharmacy

2017

Development and Validation of Sensitive

Methods for the Analysis of Some Selected

Drugs

by

Malak Youssef Al-Bathish

Thesis

Submitted in Partial Fulfillment of the requirements for the Degree of Master in Pharmaceutical Analytical Chemistry and Drug Quality

Control

Department of Pharmaceutical Technology Faculty of Pharmacy

Supervised by

Prof. Azza Abdel Kader Morsy Gazy

Professor of Pharmaceutical Analytical Chemistry and Drug Quality Control Pharmaceutical Technology Department

Faculty of Pharmacy Beirut Arab University

2017

Page | iv

Abstract Development and Validation of Sensitive Methods for the

Analysis of Some Selected Drugs

The present study aimed to develop and validate novel analytical methods for the

determination of some selected drugs (Methimazole, Memantine Hydrochloride,

Metformin Hydrochloride, Gliclazide and Canagliflozin) in their pure form or laboratory

prepared mixtures, and pharmaceutical formulations. The newly developed analytical

methods were found to be simple, sensitive, rapid and accurate.

Methimazole was determined spectrophotometrically at 610 nm after oxidation with

potassium permanganate in alkaline medium. In addition, methimazole was kinetically

determined using fixed-time method based on an indirect spectrophotometric method

using 1 mL of 50 mg % cerium (IV) nitrate in acidic medium followed by 1.2 mL of 5 mg

% methyl orange solution after 30 minutes, and then the residual methyl orange was

determined at 507 nm.

A charge transfer reaction was the basis of a spectrophotometric determination of

Memantine hydrochloride in pure form and in pharmaceutical formulation using picric

acid.

Two binary mixtures consisting of Metformin hydrochloride-Gliclazide, and Metformin

hydrochloride-Canagliflozin have been determined in their formulated tablet using RP-

HPLC. Moreover, those binary mixtures were simultaneously determined using several

spectrophotometric chemometric methods including derivative spectrophotometry, ratio

difference, derivative ratio, and extended ratio subtraction methods.

All the proposed analytical methods were validated according to ICH guidelines and

statistically compared with reference methods where no significant differences were

found.

Page | v

Table of Contents Dedication ....................................................................................................

Acknowledgement .......................................................................................

Abstract .................................................................................................... iv

Table of Contents ...................................................................................... v

List of Tables ........................................................................................... vi

List of Figures ........................................................................................ viii

List of Abbreviations .............................................................................. xi

Chapter 1

General Introduction and Literature Review .............................................. 1

Chapter 2

Development and validation of colorimetric method for the determination of Methimazole in bulk and pharmaceutical dosage form ............................ 12

Chapter 3

Kinetic spectrophotometric method for the determination of Methimazole in bulk and pharmaceutical dosage form ...................................................... 24

Chapter 4

Spectrophotometric determination of Memantine in bulk and pharmaceutical dosage form through charge transfer complexation ................................. 44

Chapter 5

Determination of Metformin-Gliclazide and Metformin-Canagliflozin in tablet formulations by RP-HPLC .............................................................. 56

Chapter 6

Chemometric determination of two binary mixtures: Metformin-Gliclazide and Metformin-Canagliflozin in tablets ................................................... 71

Appendix .................................................................................................. 98

References .............................................................................................. 103

References

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