Stability-indicating HPLC Methods for Drug Analysis - Softcover

Xu, Quanyun; Trissel, Lawrence A.

Softcover

ISBN 10: 0853694486 ISBN 13: 9780853694489

Publisher: Pharmaceutical Press, 1999

Synopsis

Stability-Indicating HPLC Methods for Drug Analysis compiles summaries of stability-indicating HPLC analytical methods that have appeared in the published literature. A first stop for pharmaceutical scientists, analytical chemists, and librarians in the quest for information about the stability of drugs. Co-published by the American Pharmaceutical Association and the Pharmaceutical Press, a division of the Royal Pharmaceutical Society of Great Britain.

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 first compilation of stability-indicating high-performance liquid chromatographic (HPLC) analytical methods-more than 500 in all-that have appeared in the published literature. The information is presented on 250 different drug entities in structured monographs containing 27 elements. The work is unique in focusing only on stability-indicating HPLC methods, a specialized subset of all HPLC methodologies. Each monograph starts with basic information on the drug product followed by one or more summaries of published stability-indicating analytical methods. The method summaries, which follow a structured format, are sufficiently detailed to allow an analyst with chromatographic experience to set up a method and begin the process of validation. By turning first to this reference, analysts will avoid the tedium of lengthy literature searches. It may also help them identify suitable, previously validated stability-indicating HPLC methods and avoid conducting expensive and time consuming validations on methods of unknown applicability that may not prove to be stability indicating. Stability-Indicating HPLC Methods for Drug Analysis will be invaluable to analysts involved in evaluating drug stability, dosage form development, quality control, and drug regulation.

Edition details

• Publisher: Pharmaceutical Press
• Publication date: 1999
• Language: English
• ISBN 10: 0853694486
• ISBN 13: 9780853694489
• Binding: Paperback
• Number of pages: 400