HPLC, LC-MS and GC Method Development and Validation: Guideline for academic and industrial scientists involved in method development and validation - Softcover

Shabir, Ghulam

Softcover

ISBN 10: 3848489546 ISBN 13: 9783848489541

Publisher: LAP LAMBERT Academic Publishing, 2012

Synopsis

The coherent body of research described in published work is concerned with new assay method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical 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 and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important 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 guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

About this title

About the Author

Dr Ghulam Shabir has a PhD in Analytical Chemistry from the University of Sunderland UK. He has worked in QC and QA in pharmaceutical industry and has received technical excellence and academic awards. He is a CSci, CChem and Fellow of the Royal Society of Chemistry, the author of sixty articles and has received top cited author status awards.

Edition details

• Publisher: LAP LAMBERT Academic Publishing
• Publication date: 2012
• ISBN 10: 3848489546
• ISBN 13: 9783848489541
• Binding: Paperback
• Language: English
• Number of pages: 96