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HPLC Method Development and Validation in Pharmaceutical Analysis by Shabir Ghulam

HPLC Method Development and Validation in Pharmaceutical Analysis

by Shabir Ghulam
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Book cover type: Paperback
  • ISBN13: 9783659321207
  • Binding: Paperback
  • Subject: N/A
  • Publisher: LAP Lambert Academic Publishing
  • Publisher Imprint: LAP Lambert Academic Publishing
  • Publication Date:
  • Pages: 492
  • Original Price: GBP 65.57
  • Language: English
  • Edition: N/A
  • Item Weight: 717 grams
  • BISAC Subject(s): Chemistry / General

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.

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