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Doody's Review ServiceReviewer: Rahmat M. Talukder, PhD, RPh (West Coast University School of Pharmacy)
Description: This book provides readily retrievable HPLC methods for stability studies of 572 drugs that have been published as original research works in various literatures. The information is presented in monograph format that includes basic physicochemical properties of the drug (e.g., solubilities, pKa, molecular weight, formula, etc.) and a description of analytical methods with instrumentation.
Purpose: This is intended as a ready reference to published papers on stability studies using HPLC methods, relevant objectives for pharmaceutical product development. It will be especially helpful to scientists involved in analytical method development as well as in stability studies.
Audience: The authors target pharmaceutical scientists dealing with determination of stability of dosage forms, but the book will be a handy reference for anyone involved in the drug development process, as stability studies are legally required. It also will be a good reference for regulatory agencies. Lawrence Trissel is well known for his book, Handbook on Injectable Drugs, 14th edition (American Society of Health-System Pharmacists, 2007). He and Q. A. Xu have published a number of research papers over the past several years.
Features: The title speaks for itself. A total of 1,028 HPLC analytical methods on stability studies of 572 drugs are detailed. Drugs are arranged alphabetically by their generic name and a brief description of physicochemical properties of the drug substance begins each entry. In describing HPLC methodologies and instrumentation, the authors have included many critical issues, e.g., salt forms of the drug, standard solution preparation, sample preparation, decomposition techniques, LOD, LOQ, etc. In addition, multiple methods for the same compound, as represented in the literature, are presented. The authors use a descriptive style of reporting solubility of a drug (e.g., very soluble, sparingly soluble, etc.), but it would be more useful if numbers (e.g., mg/mL) were used.
Assessment: Stability study is an integral part of pharmaceutical product development. An analytical scientist spends a substantial amount of time searching for published articles on HPLC methodologies on a relevant drug substance. This book is a compilation of summaries of papers published in various journals on stability studies of pharmaceutical dosage forms using HPLC methods. Multiple methods on the same drug published by different scientists are included. Therefore, this will be a useful tool for scientists who are engaged in pharmaceutical product development, especially in stability studies.