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HPLC Method Development for Pharmaceuticals Pdf Free

HPLC Method Development for Pharmaceuticals: This book is written by Satinder Ahuja and Henrik Rasmussen which you can download freely in pfd format. High-pressure or high-performance liquid chromatography (HPLC) is the method of choice for verifying the purity of new drug candidates, monitoring changes during scale-up or review of synthetic procedures, evaluating new formulations, and performing final drug product control/assurance . .
The goal of this book is to provide a broad overview of modern HPLC method development that addresses these unique concerns. In order to provide a single source of information, an attempt has been made to address all topics relevant to HPLC method development.

The goal of this book is to provide a broad overview of modern HPLC method development that addresses these unique concerns. In order to provide a single source of information, an attempt has been made to address all topics relevant to HPLC method development.

Description:

Book Name HPLC Method Development for Pharmaceuticals
Author of Book Satinder Ahuja and Henrik Rasmussen
Edition  
Language English
Format PDF
Category Pharmaceuticals Books

Overview of HPLC Method Development for Pharmaceuticals Pdf Free

According to Satinder Ahuja and Henrik Rasmussen, The book is intended to be especially useful to both novice and experienced HPLC method development chemists in the pharmaceutical industry and to managers looking to update their knowledge. We would like to thank the authors for their contributions that will make this book serve as a definitive reference source on HPLC method development for researchers, analysts, managers, and regulators in the pharmaceutical industry.

Optimizing selectivity and detectability have been major goals in HPLC separations for some time; 3,4 however, HPLC practitioners who are not trained in the physical sciences are reluctant to use theoretical considerations in method development. An attempt has been made in Chapter 2 to overcome this reluctance, using intuitive arguments. The essential fundamental theoretical concepts of HPLC are largely explained phenomenologically. The practical applicability of the concepts and equations is shown. Two main aspects comprise the theory of HPLC: the kinetic aspect of the migration of the chromatographic zone is responsible for band broadening and the thermodynamic aspect is responsible for retention of the analyte on the column. The dispersion process of the chromatographic zone in the column, generally called efficiency, is one of the important descriptors of the chromatographic system. The migration rate of the chromatographic zone is determined by the competitive interactions of the analyte with the stationary phase. In the isocratic separation mode, this rate is constant and the common analyte retention characteristic is the retention time (the ratio of column length to migration rate). Several equations have been provided to help the reader achieve optimal separations.

Key features

  • Covers the requirements for HPLC in a pharmaceutical environment, including software and hardware validation strategies to enable 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

Topics of this Edition

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.).

About the Author

Satinder Ahuja is a leading expert in improving water quality. He earned his Ph.D. in analytical chemistry from Philadelphia University of the Sciences. He worked for Novartis Corp. in various leadership positions for more than 25 years and taught as an adjunct professor at Pace University for more than 10 years. As president of Ahuja Consulting, he advises on water quality issues related to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World (ROW) Foundation, Dr. Ahuja has organized numerous global symposiums on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous articles and more than 25 books. His latest books are Contaminants in our water (ACS, 2020); Assessment of water quality to prevent future disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017).
 
Henrik Rasmussen
Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA

 

 

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