Stability-indicating HPLC Methods for Drug Analysis - Hardcover

"'There is little doubt that the book will be absolutely invaluable to analysts evaluating the stability of drug substances and to those engaged in dosage form development.... I simply cannot imagine any method-developing HPLC analysts who would not want to have this book on his or her shelf as a ready reference.' Pharmaceutical Development and Technology 2005; 1: 145. 'This book is a very valuable one to have on the shelves for anyone involved in quality control and stability studies.' Pharmaceutical Journal 2000; 264: 309. 'Due to the fact that most of the efforts of analytical method development within the pharmaceutical sciences go into establishing and validating a stability indicating HPLC method, the book will save analytical chemists time and efforts in identifying a suitable stability-indicating HPLC method available in the published literature. Indeed, the usefulness of this book comes from the authors' effort to exclude general HPLC methods primarily used for the measurement of drug concentrations in biological matrices, so that only stability-indicating methods are compiled in this book. For readers not only wishing to develop HPLC methods as a means of studying drug stability but also carrying out research in the field of dosage form development, quality control, and drug regulation, this book will be an indispensable one.' Pharmaceutical Research 2003; 20(12): 2046."

This is a compilation of the literature on approximately 1000 stability-indicating HPLC (high-performance liquid chromatography) analytical methods for drugs.The determination of drug stability is an essential part of pharmaceutical formulation development and is of concern to pharmaceutical scientists involved in drug research, quality control, and drug regulation. Normally, high-performance liquid chromatography (HPLC) methods are used in stability studies since the technique can produce reliable analytical results quickly and relatively cheaply. However, the development of stability-indicating HPLC methods can be an expensive and complex process.This publication summarises the hundreds of validated stability-indicating HPLC methods that have been reported in the literature for approximately 500 of the most commonly used drugs. The detailed, structured drug monographs, provide a thorough description of various HPLC methods which could be used, enabling the analyst to avoid undertaking novel method development or conducting an extensive literature search. Approximately 1000 stability-indicating HPLC methods are included in this edition.