HPLC Method Development and Validation in Pharmaceutical Analysis: Handbook for Analytical Scientists

This handbook is concerned with new chromatographic method development and validation using novel systematic approaches for pharmaceutical compounds. The first stage of the research was to study how method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners in the pharmaceutical industry. Furthermore, it was recognised that this protocol should satisfy the requirements of the major regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC, LC-MS and GC. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of single guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Dr Ghulam Shabir, PhD from University of Sunderland. He worked for top pharmaceutical industries in leadership roles for 27 years and simultaneously served as visiting Professor and Fellow for several Universities including OXFORD Brookes. He is the author of 65 peer-reviewed papers, 3 books and has received many top cited author status awards.