HPLC Method Development for PharmaceuticalsEdited by
- Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
- Henrik Rasmussen, Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA
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.
For researchers, analysts, managers, and regulators of the pharmaceutical industry
Separation Science and Technology
Hardbound, 532 Pages
Published: May 2007
Imprint: Academic Press
- 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.).