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 Meth...

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Bibliographic Details
Corporate Author: ScienceDirect (Online service)
Other Authors: Ahuja, Satinder, 1933-, Rasmussen, Henrik
Format: eBook
Language:English
Published: [Place of publication not identified] : Academic Pr, 2007.
Series:Separation science and technology (San Diego, Calif.) ; v. 8.
Subjects:
Online Access:Connect to the full text of this electronic book

MARC

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520 |a 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. 
505 0 |a 1. Overview (Satinder Ahuja). -- 2. HPLC Theory (Y.V. Kazakevich). -- 3. HPLC Columns and Packings (U.D. Neue <IT>et al</IT>.). -- 4. Column Characterization and Selection (D. Visky). -- 5. Chiral Separations (Xiande Wang <IT>et al</IT>.). -- 6. Contemporary Liquid Chromatographic Systems for Method Development (M. Swartz). -- 7. Hyphenated Techniques (D.L. Norwood <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 17. Troubleshooting HPLC Methods (H. McNair). -- 18. Molecularly Imprinted Polymers as Sorbents for Separations and Extractions (M.T. Koesdjojo <IT>et al</IT>.). 
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