Capillary Electrophoresis Methods for Pharmaceutical Analysis

Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control.- Provides current status and future developments in CE analysis of pharmaceuticals.- Explains how to develop and validate methods.- Includes major pharmaceutical applications including assays and impurity testing.

Preface1. Overview of Capillary Electrophoresis in Pharmaceutical Analysis2. Theoretical Consideration in Performance of Various Modes of CE 3. Equipment Considerations for Capillary Electrophoresis4. Method Development for Pharmaceutical Analysis5. Role of CE in Drug Substance and Drug Product Development6. General Considerations to Improve Performance of CE Methods7. Overview of Current Regulatory Guidance 8. Qualification of CE Instrumentation9. Robustness Testing of CE Methods10. Validation of Analytical Methods11. The Need for CE Methods in Pharmacopeial Monographs12. CE in Impurity Profiling of Drugs13. Ion Analysis14. Role of CE in Biopharmaceutical Development and Quality Control15. Capillary Electrophoresis and Bioanalysis16. CE as Orthogonal Technique to Chromatography17. Capillary Electrochromatography of Pharmaceuticals18. Coupling CE and Chip-based Devices and Mass Spectrometry