Steen Honoré Hansen and Stig Pedersen-Bjergaard (Eds.): Bioanalysis of pharmaceuticals: sample preparation, separation techniques and mass spectrometry

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Bioanalysis of pharmaceuticals: sample preparation, separation techniques and mass spectrometry

Steen Honoré Hansen and Stig Pedersen-Bjergaard (Eds.)

Wiley

ISBN: 978-1-118-71681-6

Hardcover, 312 pages, July 2015, €135.00/£100.00

Book’s topic This book is an introductory student textbook covering various instrumental analytical approaches for the determination of pharmaceuticals in biological samples. It provides an introduction to important bioanalytical techniques and applications in the context of pharmaceutical bioanalysis. Many detailed examples are included. From the instrumental point of view, the clear focus is on chromatography and mass spectrometry. Applications include determinations of low-molecular drug substances, peptides, and proteins in biological fluids.

Contents The book consists of 11 chapters. The first three chapters provide a solid discussion of the basics of pharmaceutical bioanalysis. The initial chapter delivers an introduction to the current role of bioanalysis and the particular requirements in the context of pharmaceutical industry and clinical laboratories. The following two chapters are concerned with the chemical properties of drug substances and the characteristics of various biological fluids. Chapters 4 and 5 discuss general aspects of chromatographic theory and quantitative chromatographic analysis. Chapter 6 is devoted to sample preparation techniques, which play an essential role within the overall bioanalytical process. Classical concepts like liquid–liquid extraction or solid-phase extraction are discussed in detail. Current trends concerning high-throughput sample preparations, “dilute and shoot” strategies, and alternative concepts (e.g., microdialysis) are also covered. In Chapters 7 and 8, instrumental and practical aspects of high-performance liquid chromatography (Chapter 7) and gas chromatography (Chapter 8) are presented. In both chapters, hyphenation to mass spectrometry is treated in detail. Some recent trends concerning ultrahigh-performance liquid chromatography and corresponding stationary phase materials or combinations of ion mobility and mass spectrometry are also presented. Chapters 9 and 10 are the key chapters of the book. Representative examples of bioanalytical determinations of pharmaceuticals are discussed. Both chapters are based on the theoretical background of the previous chapters but focus now on application aspects of real pharmaceutical sample analysis. In Chapter 9, the determination of small-molecule drugs is discussed, while Chapter 10 deals with peptide and protein drugs in biological fluids. Chapter 11 presents regulatory aspects of bioanalysis. This final chapter is written with the pharmaceutical industry’s perspective.

Comparison with the existing literature This book is the first student textbook focusing on chromatographic and mass spectrometric techniques for the determination of pharmaceuticals in biological samples. The content of Chapters 4–8 can be found in various other textbooks of bioanalysis or instrumental analysis. However, it is convincing to present these general analytical topics in combination with applied aspects of pharmaceutical analysis.

Critical assessment The strength of the present book is the presentation of important aspects of pharmaceutical bioanalysis within an educational frame with many examples accompanied by questions and answers that will guide undergraduate students in their self-study efforts. The authors decided to focus on chromatographic and mass spectrometric techniques. Several recent trends in chromatography and mass spectrometry are addressed. However, in future editions of the book, important developments of comprehensive two-dimensional separations such as GC x GC or HPLC x HPLC should be included since the enhanced peak capacity associated with these techniques is very important for the study of complex biological samples.

Readership recommendation The book has a strong focus on educational aspects of presentation. It can be highly recommended to undergraduate pharmacy and chemistry students as well as their teachers.

Summary Bioanalysis of pharmaceuticals: sample preparation, separation techniques and mass spectrometry is an introductory student textbook in the field of pharmaceutical bioanalysis. Special attention is paid to the concepts and applications of chromatographic separation techniques in hyphenation with mass spectrometry. The book emphasizes an educational presentation of bioanalytical methods and applications. It is an up-to-date introduction to important bioanalytical approaches for the determination of pharmaceuticals.