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.
Table of Contents
Preface1. Overview of Capillary Electrophoresis in Pharmaceutical Analysis
2. Theoretical Consideration in Performance of Various Modes of CE
3. Equipment Considerations for Capillary Electrophoresis
4. Method Development for Pharmaceutical Analysis
5. Role of CE in Drug Substance and Drug Product Development
6. General Considerations to Improve Performance of CE Methods
7. Overview of Current Regulatory Guidance
8. Qualification of CE Instrumentation
9. Robustness Testing of CE Methods
10. Validation of Analytical Methods
11. The Need for CE Methods in Pharmacopeial Monographs
12. CE in Impurity Profiling of Drugs
13. Ion Analysis
14. Role of CE in Biopharmaceutical Development and Quality Control
15. Capillary Electrophoresis and Bioanalysis
16. CE as Orthogonal Technique to Chromatography
17. Capillary Electrochromatography of Pharmaceuticals
18. Coupling CE and Chip-based Devices and Mass Spectrometry
