HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals

1st Edition - May 15, 2007

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  • Editors: Satinder Ahuja, Henrik Rasmussen
  • Hardcover ISBN: 9780123705402
  • eBook ISBN: 9780080554198

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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.

Key Features

  • 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


For researchers, analysts, managers, and regulators of the pharmaceutical industry

Table of Contents

  • 1. Overview (Satinder Ahuja).

    2. HPLC Theory (Y.V. Kazakevich).

    3. HPLC Columns and Packings (U.D. Neue et al.).

    4. Column Characterization and Selection (D. Visky).

    5. Chiral Separations (Xiande Wang et al.).

    6. Contemporary Liquid Chromatographic Systems for Method Development (M. Swartz).

    7. Hyphenated Techniques (D.L. Norwood et al.).

    8. HPLC Sample Preparation (G. Slack, N.H. Snow).

    9. Instrument and Software Qualification and Validation (D. Van Geel).

    10. Pharmaceutical Development: From Pre-clinical to Post Approval (K. Bynum).

    11. HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications (Xiaoying Xu, W. Korfmacher).

    12. HPLC Method Development in Early Phase Pharmaceutical Development (H.T. Rasmussen et al.).

    13. HPLC Method Development in Late Phase Pharmaceutical Development (M. Ilias Jimidar).

    14. Use of HPLC for In-process Testing (C. Richardson).

    15. Method Development for Biomolecules (D.E. Raynie, J.L. Driver).

    16. Method Validation (M. Ilias Jimidar et al.).

    17. Troubleshooting HPLC Methods (H. McNair).

    18. Molecularly Imprinted Polymers as Sorbents for Separations and Extractions (M.T. Koesdjojo et al.).

Product details

  • No. of pages: 532
  • Language: English
  • Copyright: © Academic Press 2007
  • Published: May 15, 2007
  • Imprint: Academic Press
  • Hardcover ISBN: 9780123705402
  • eBook ISBN: 9780080554198

About the Editors

Satinder Ahuja

Satinder Ahuja
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).

Affiliations and Expertise

President, Ahuja Consulting for Water Quality, Calabash, NC, USA

Henrik Rasmussen

Affiliations and Expertise

Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA

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