Analysis for pharmaceutical scientists

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Handbook of Pharmaceutical Analysis (vol. 17, Drugs and The Pharmaceutical Sciences)edited by Lena Ohannesian and Anthony J. StreeterMarcel Dekker, Inc. 2002. US$195 hdbk(xii+585 pages) ISBN 0 8247 0462 2The disclosure of the human genome, the study of metabolic pathways of drug candidates and the detection of illicit drug abuse in doping scandals; in all three examples, modern analytical techniques play a fundamental and enabling role. Without doubt, the success of pharmaceutical research and development today depends significantly on reliable and robust analytical methods. A basic knowledge of these methods is therefore of increasing importance to all scientists working in this field.The Handbook of Pharmaceutical Analysis aims to provide scientists with up-to-date information about analytical methodologies most frequently used in pharmaceutical analysis. The individual chapters are written by experts, both from academia and from industry, with many years of experience in developing and applying analytical methods.The initial chapter on drug polymorphism sets the scene. It has been shown that different polymorphs of a drug can have significantly different properties, such as solubility and bioavailability. Therefore, to pick the right polymorph is of great importance for successful drug development. The analytical methods that can be used to detect and identify polymorphs are described and demonstrated using well-chosen examples.Before an analytical method can be used it is necessary to obtain a sample and this problem is discussed in the second chapter. After an overview of the different types of sample, a variety of sample preparation techniques and their underlying theoretical principles are presented.The book also covers well-established separation methods and the most important analytical methods for compound identification, giving a thorough overview of theory and instrumentation for each method. This includes high-performance liquid chromatography, capillary electrophoresis, atomic spectroscopy, UV/Vis spectroscopy, luminescence and fluorescence spectroscopy, vibrational spectroscopy, mass spectrometry (MS), and solid-state nuclear magnetic resonance spectroscopy (NMR).This book is distinguished from other textbooks on analytical methods by its emphasis on pharmaceutical applications. Many examples can be found throughout the book that demonstrate the use of analytical methods in pharmaceutical research. The major areas covered are polymorphism studies using vibrational spectroscopy and solid-state NMR, in vivo and in vitro metabolism studies using MS, clinical diagnostics and drug monitoring using immunoassay techniques.Another aspect specific to analytical methods used in a pharmaceutical context is compliance with the requirements of the regulatory authorities. The final chapter discusses the problem of process validation in depth.This book will be a good introduction to analytical methods and their application in pharmaceutical research, for advanced undergraduate and graduate students. It will help them achieve a good basic knowledge of the different methods, and the use of relevant examples will assist students to relate what they read to their own experiences. The book will also be useful as a reference for chemists, biochemists and pharmaceutical scientists who use analytical methods in their everyday work. For those who want to obtain a deeper understanding, the ∼2000 references provide a source of more detailed publications.