HPLC Method Development for Pharmaceuticals

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.

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.).