Stability-Indicating Hplc Methods for Drug Analysis - Hardcover

Xu, Quanyun A; Trissel, Lawrence A.

Hardcover

ISBN 10: 0917330951 ISBN 13: 9780917330957

Publisher: American Pharmaceutical Association, 1999

Synopsis

The first compilation of over 500 stability-indicating high-performance liquid chromatographic (HPLC) analytical methods that have appeared in the published literature. The information is presented as a series of monographs on 250 different drug entities arranged in alphabetical order, and summarized in a format composed of 27 elements. Each monograph starts with basic information on the drug product followed by one or more summaries of published stability-indicating analytical methods. This unique reference focuses only on stability-indicating HPLC methods, and will reduce the time-consuming task of finding stability-indicating assays.

About this title

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.

Edition details

• Publisher: American Pharmaceutical Association
• Publication date: 1999
• ISBN 10: 0917330951
• ISBN 13: 9780917330957
• Binding: Hardcover
• Language: English
• Number of pages: 391