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.Stability-Indicating Assays Impurity profiling is essential also in stability-indicating studies to separate and detect potential degradation products. ... A number of stability-indicating CE methods were applied to both stored drug substance and various formulations. ... tablet formulation was developed, optimized, and fully validated according to ICH guidelines and submitted to the regulatory authorities.
|Title||:||Capillary Electrophoresis Methods for Pharmaceutical Analysis|
|Author||:||Satinder Ahuja, Mohamedilias Jimidar|
|Publisher||:||Elsevier - 2011-08-09|