Items related to Stability-Indicating HPLC Method for Drug Analysis,...
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.
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Review:
"'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."
From the Back Cover:
Stability-Indicating HPLC Methods for Drug Analysis is the only compilation of stability-indicating high-performance liquid chromatographic (HPLC) analytical methods—more than 850 in all—that have appeared in published literature. Invaluable to analysts involved in evaluating drug stability, dosage form development, quality control, and drug regulation, this reference will make lengthy literature searches unnecessary and help identify suitable, previously validated stability-indicating HPLC methods.
Also, with this compilation, analysts will avoid conducting expensive and time-consuming validations on methods of unknown applicability that may not prove to be stability indicating.
Featuring:
*A compilation of more than 850 stability-indicating HPLC analytical methods—more than 350 new to this edition—that have been described in the published literature
*Information presented on more than 450 different drug entities—more than 200 new to this edition—in structured monographs containing 28 elements
*A more in-depth, extensive description of the HPLC analysis presented in the literature
*Unique focus on stability-indicating HPLC methods, a specialized subset of all HPLC methodologies
*Index
About the Authors
Quanyun A. Xu, PhD, is Research Scientist, Clinical Pharmaceutics Research Program, Division of Pharmacy, University of Texas M.D. Anderson Cancer Center, Houston Texas.
Lawrence A. Trissel, FASHP, is Director of the program.
Co-published by the American Pharmacists Association, Washington, DC, the leading national professional association of pharmacists in the United States, and the Pharmaceutical Press, publications division of the Royal Pharmaceutical Society of Great Britain, London, UK.
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- PublisherPharmaceutical Press
- Publication date2008
- ISBN 10 085369723X
- ISBN 13 9780853697237
- BindingHardcover
- Edition number3
- Number of pages704
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