HPLC Method Development for Pharmaceuticals
- Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
- Henrik Rasmussen, Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA
For researchers, analysts, managers, and regulators of the pharmaceutical industry
- Published: May 2007
- Imprint: ACADEMIC PRESS
- ISBN: 978-0-12-370540-2
Review in Doody's 2008, by Joseph Boullata, PharmD(University of Pennsylvania College of Nursing): "This book is written with pharmaceutical scientists in mind, regardless of their level of experience with HPLC method development. By extension, it would be valuable for managers and regulators as well. It may also be of value to those managing a lab or research program in the academic setting. The 18 chapters are written by 35 contributors, mostly from the U.S., with just over half from the pharmaceutical industry. The book is divided into two major sections, one a state-of-the-science review of HPLC and one on the unique needs in a pharmaceutical setting. This latter section is what makes the book most useful to the intended audience. It addresses topics such as method development for each phase in the drug development process, strategies for software/hardware validation, and prevention/troubleshooting problems. There is lots of concern for instrument qualification and validation in meeting regulatory requirements. The role of HPLC in tandem with mass spectrometry and other detection methods for assaying biological samples does not receive nearly as much attention. Assessment: The book is clearly superior to the many books on HPLC methods development which do not address pharmaceutical issues to any great extent, if at all. There is generous use of figures and tables throughout and very little overlap across chapters. Weighted Numerical Score: 88 - 3 Stars"
Table of Contents1. 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.).