HPLC method development for pharmaceuticals / edited by Satinder Ahuja, Henrik Rasmussen.

Format:

Book

Contributor:

Ahuja, Satinder, 1933-

Rasmussen, Henrik.

Series:

Separation science and technology (San Diego, Calif.) ; v. 8.

Separation science and technology ; v. 8

Language:

English

Subjects (All):

High performance liquid chromatography--Methodology.

High performance liquid chromatography.

Drugs--Analysis.

Drugs.

Drug development.

Physical Description:

1 online resource (xvii, 513 pages) : illustrations

Edition:

1st ed.

Place of Publication:

Amsterdam ; Boston : Elsevier, Academic Press, 2007.

Language Note:

English

Summary:

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

Contents:

Front Cover; HPLC METHOD DEVELOPMENT FOR PHARMACEUTICALS; Copyright Page; CONTENTS; PREFACE; CONTRIBUTORS; Chapter 1. Overview of HPLC Method Development for Pharmaceuticals; I. Introduction; II. Theoretical Considerations; III. HPLC Columns and Column Packings; IV. Column Selection; V. Chiral Separations; VI. Contemporary HPLC; VII. Hyphenated Methods; VIII. Sample Preparation; IX. Instrument Qualification and Software Validation; X. Pharmaceutical Development; XI. Drug Discovery; XII. Early Phase Method Development; XIII. Late Phase Development; XIV. In-Process Testing

XV. Method Development for Biomolecules; XVI. Method Validation; XVII. Troubleshooting; XVIII. Molecularly Imprinted Polymers; References; Chapter 2. HPLC Theory; Abstract; I. Introduction; II. Basic Chromatographic Descriptors; III. Efficiency; IV. Resolution; V. Main Components of the Retention Mechanism; VI. General Column Mass Balance; VII. Partitioning Model; VIII. Adsorption Model; IX. Void Volume Considerations; X. Thermodynamic Relationships; XI. Secondary Equilibria; XII. Salt Effect; XIII. Effect of Different Counteranions; XIV. Inclusion of Secondary Equilibria in the Mass Balance

XV. Conclusions; References; Chapter 3. HPLC Columns and Packings; Abstract; I. Introduction; II. Column Chemistry; III. Speed and Resolution; IV. Specialty Columns from Nanobore to Preparative Chromatography; V. Summary; References; Chapter 4. Column Characterization and Selection; Abstract; I. Introduction; II. Characteristics of RP-HPLC Columns and Chromatographic Tests; III. Column Classification and Selection; IV. Conclusions; Acknowledgment; References; Chapter 5. Chiral Separations; Abstract; I. Introduction; II. Separation of Enantiomers on HPLC Chiral Stationary Phases

III. Practical Guidelines to Chiral HPLC of Pharmaceuticals; IV. Conclusions; References; Chapter 6. Contemporary Liquid Chromatographic Systems for Method Development; Abstract; I. Introduction; II. Traditional Instrumentation for HPLC Method Development; III. Contemporary Method Development Systems; IV. Migrating Methods from HPLC to UPLC; V. UPLC Applications in Pharmaceutical Analysis; VI. Summary and Conclusions; Acknowledgments; References; Further Reading; Chapter 7. Hyphenated Techniques; Abstract; I. Introduction and Background; II. Combined Liquid Chromatography/Mass Spectrometry

III. Combined Liquid Chromatography/Nuclear Magnetic Resonance Spectroscopy; IV. Conclusions; Acknowledgments; References; Chapter 8. HPLC Sample Preparation; Abstract; I. Introduction; II. Fundamentals of Extraction and Chemical Equilibrium; III. Choice of Samples Preparation; IV. Direct Injection; V. Liquid-Liquid Extraction; VI. Solid-Phase Extraction; VII. Solid Samples; VIII. Additional Sample Preparation Methods; IX. Conclusions; References; Chapter 9. Instrument Qualification and Software Validation; Abstract; I. Introduction; II. Definitions; III. Qualification Model; IV. Discussion: Case Study HPLC

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-281-07067-X

9786611070670

0-08-055419-9

OCLC:

476114638