This volume reflects the changes that have taken place in the pharmaceutical industry over the last ten years, most notably the increased importance attached to the question of chirality, the growing influence of biotechnology and the need for more rigorous documentation and validation of analytical methods and procedures.The first part of this book deals with the application of new technology to pharmaceutical and biomedical analysis, reflecting the present needs for increased speed, sensitivity and selectivity in the analysis of drugs. The second chapter provides an overview of capillary electophoresis, which represents one of the most inportant analytical developments to impact directly on pharmaceutical development in recent years. Although not a chromatographic technique, capillary electrophoresis was considered too important to be ignored.Over the last 25 years, liquid chromatography has grown into a mature analytical technique and many of the fundamental issues concerned with retention and separation are well defined. The practitioners of modern liquid chromatography spend as much time in the development of techniques for sampling handling and automation as they do in the development of the separation. Therefore, Part Two of this book describes some of the recent advances in the areas of sample handling and the isolation of compounds from biological samples, including solid phase extraction, restricted access media for direct injection, coupled column technology and microdialysis. Similarily, Part Three contains two chapters concerned with liquid chromatographic methods for the isolation of drug substances, peptides and proteins from other complex media.The pharmaceutical industry and the process of drug development are highly regulated and the increasing importance that the regulatory authorities attach to validation has had a significant impact on the analytical techniques used for the analysis of drugs. Although this has increased the workload of analysts in the pharmaceutical industry, it has also improved the quality of analytical methods used in the support of investigational and new drug applications as well as the quality of methods published more recently in the literature. Consequently, Part Four of this volume describes approaches to the optimization and validation of liquid chromatography methods for the analysis of drugs in the bulk form, in pharmaceutical formulations and biological fluids.
For undergraduate pharmacy students and chemistry students; post-graduate students and faculty in analytical chemistry, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics and medicinal chemistry; and analytical scientists in government, pharmaceutical industry and biotechnology industry.
Table of Contents
Introduction. Part One: Application of New Technology to Pharmaceutical and Biomedical Analysis. Pharmaceutical and biomedical applications of capillary electrophoresis (D.K. Lloyd). Novel approaches to the liquid chromatographic analysis of primary amines, amino acids and peptides (C.M. Riley et al.). Fast liquid chromatography for the analysis of enantiomers (S.R. Perrin). Part Two: Recent Developments in the Isolation of Compounds from Biological Matrices. Solid phase extraction for sample preparation (M. Zief, S.V. Kakodkar). Application of restricted-access media to the direct analysis of biological samples (J.A. Perry). On-line microdialysis sampling (C.M. Riley et al.). Multi-column approaches to chiral bioanalysis by liquid chromatography (W.J. Lough, T.A.G. Noctor). Part Three: Liquid Chromatography Methods for the Preparation of Drug Substances. Application of preparative liquid chromatography techniques in new drug discovery (A.J. Mical, M.A. Wuonola). Application of liquid chromatography to the purification of peptides and proteins (S.R. Narayanan). Part Four: Development and Validation of Analytical Methods in Pharmaceutical and Biomedical Research. Development and validation of liquid chromatography assays for the regulatory control of pharmaceuticals (R.J. Bopp et al.). Comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry (J.R. Lang, S.M. Bolton). Index.
School of Health Sciences, University of Sunderland, UK
Affiliations and Expertise
Department of Oncology, McGill University, Montreal, Quebec, Canada
President of Riley and Rabel Consulting Services. Former Vice President of Analytical R&D at DuPont Pharmaceutical Company, and Vice President of ChemPharm at ALZA (a division of Johnson and Johnson) as well as a member of the ICH Expert Working Group on Impurities.
Affiliations and Expertise
President of Riley and Rabel Consulting Services, Maryville, MO, USA