HPLC Method Development for Pharmaceuticals

Satinder Ahuja and Henrik Rasmussen (Eds.)978-0-12-370540-2

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

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Table of contents :
Content:
Preface
Pages xiii-xiv
Satinder (Sut) Ahuja, Henrik Rasmussen

Contributors
Pages xv-xvii

1 Overview of HPLC method development for pharmaceuticals Original Research Article
Pages 1-11
Satinder Ahuja

2 HPLC theory Original Research Article
Pages 13-44
Y.V. Kazakevich

3 HPLC columns and packings Original Research Article
Pages 45-83
Uwe D. Neue, Bonnie A. Alden, Edward R. Grover, Eric S. Grumbach, Pamela C. Iraneta, Alberto Méndez

4 Column characterization and selection Original Research Article
Pages 85-109
Dóra Visky

5 Chiral separations Original Research Article
Pages 111-144
Xiande Wang, Weiyong Li, Henrik Rasmussen

6 Contemporary liquid chromatographic systems for method development Original Research Article
Pages 145-187
Michael E. Swartz

7 Hyphenated techniques Original Research Article
Pages 189-235
Daniel L. Norwood, James O. Mullis, Thomas N. Feinberg

8 HPLC sample preparation Original Research Article
Pages 237-268
Gregory C. Slack, Nicholas H. Snow

9 Instrument qualification and software validation Original Research Article
Pages 269-296
Dave Van Geel

10 Pharmaceutical development: From pre-clinical to post approval Original Research Article
Pages 297-316
Kevin C. Bynum

11 HPLC method development for drug discovery LC-MS assays in rapid PK applications Original Research Article
Pages 317-351
Xiaoying Xu

12 HPLC method development in early phase pharmaceutical development Original Research Article
Pages 353-371
Henrik T. Rasmussen, Kelly A. Swinney, Sheetal Gaiki

13 HPLC method development in late phase pharmaceutical development Original Research Article
Pages 373-405
M. Ilias Jimidar, Maurits De Smet

14 Use of HPLC for in-process testing Original Research Article
Pages 407-423
Christine F. Richardson

15 Method development for biomolecules Original Research Article
Pages 425-439
Julee L. Driver, Douglas E. Raynie

16 Method validation Original Research Article
Pages 441-458
M. Ilias Jimidar, Patrick Heylen, Maurits De Smet

17 Troubleshooting in high performance liquid chromatography Original Research Article
Pages 459-477
Harold Mcnair, Lee N. Polite

18 Molecularly imprinted polymers as sorbents for separations and extractions Original Research Article
Pages 479-503
Myra T. Koesdjojo, Yolanda H. Tennico, Vincent T. Remcho

Index
Pages 505-513