HPLC Method Development for Pharmaceuticals, Volume 8 (Separation Science and Technology) (Separation Science and Technology)

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 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 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 "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." -- Book Jacket Provides an overview of modern high pressure, or high performance, liquid chromatography (HPLC) method development that addresses various concerns. This work includes a review of the state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, and sample preparation.