HPLC Method Development for Pharmaceuticals

Satinder Ahuja · Henrik Rasmussen

Sep 2011 · Elsevier

About this ebook

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.

HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.

• Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
• Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
• Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

About the author

Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017).