HPLC Method Development for Pharmaceuticals

高效液相色譜在制藥工業中的創新性應用

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Author: Satinder Ahuja, Henrik Rasmussen
Language: English
ISBN/ISSN: 9787030215598
Published on: 2008-01
Hardcover

The aim of this book is to provide an extensive overview of modern HPLC method development that addresses these unique concerns. For the purpose of providing a single source of information, an attempt has to been made to address all topics relevant to HPLC method development. The book is comprised of two major sections:
1.Review and update of the current sate of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instruction (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation and on providing a practical perspective.
2.Focus on unique requirements for HPLC in a pharmaceutical setting.

1.Overview of HPLC Method Development for Pharmaceuticals
2.HPLC Theory
3.HPLC Columns and Packings
4.Column Characterization and Selection
5.Chiral Separations
6.Contemporary Liquid Chromatographic Systems for Method Development
7.Hyphenated Techniques
8.HPLC Sample Preparation
9.Instrument Qualification and Software Validation
10.Pharmaceutical Development: From Pre-Clinical to Post Approval
11.HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications
12.HPLC Method Development in Early Phase Pharmaceutical Development
13.HPLC Method Development in Late Phase Pharmaceutical Development
14.Use of HPLC for In-process Testing
15.Method Development for Biomolecules
16.Method Validation
17.Troubleshooting in High Performance Liquid Chromatography
18.Molecularly Imprinted Polymers as Sorbents for Separations and Extractions



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