Capillary Electrophoresis Methods for Pharmaceutical Analysis

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Overview

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.

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Product Details

Meet the Author

Satinder Ahuja earned his Ph.D. in analytical chemistry from the University of the Sciences, Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years while simultaneously teaching and guiding research as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on quality issues relating to chemicals/pharmaceuticals and water. Dr. Ahuja has published numerous papers and more than eighteen books. Two of his latest books are entitled "Water Reclamation and Sustainability" (Elsevier) and Comprehensive "Water Quality and Purification" (Elsevier). Others include "Monitoring Water Quality: Pollution Assessment, Analysis, and Remediation" (Elsevier, 2013); "Novel Solutions to Water Pollution" (ACS Symposium Volume, 2013); "Handbook of Water Purity and Quality" (Elsevier, 2009); and "Arsenic Contamination of Water: Mechanism, Analysis, and Remediation" (Wiley, 2008). A member of the executive committee of Rivers of the World Foundation (ROW), Dr. Ahuja is an expert on improving water quality and has organized numerous global symposia on this topic (American Chemical Society, UNESCO, etc.) In 2013, he gave a lecture on the nexus of food, energy, and water and chaired a symposium on the subject for the American Chemical Society meeting in New Orleans.
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Table of Contents

Preface
1. 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
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