Determination of the inorganic degradation products sulfate and sulfamate in the antiepileptic drug topiramate by capillary electrophoresis |
| |
Authors: | A. Klockow-Beck A. Nick St. Geisshuesler D. Schaufelberger |
| |
Affiliation: | a The R.W. Johnson Pharmaceutical Research Institute, a Division of Cilag AG, Analytical Development, Hochstrasse 201, CH-8205 Schaffhausen, Switzerland b The R.W. Johnson Pharmaceutical Research Institute, Analytical Development, Route 202, Raritan, NJ 08869, USA |
| |
Abstract: | A capillary electrophoresis (CE) method has been developed as an alternative method for the determination of the inorganic degradation products sulfate and sulfamate in topiramate drug product and drug substance, currently performed by ion chromatography. The anions are separated in a background electrolyte containing potassium chromate and boric acid, followed by indirect UV detection. By adding tetradecyltrimethylammonium bromide to the electrolyte, analysis is performed under co-electroosmotic flow conditions. Variations in injection volumes and migration times are compensated for by use of an internal standard. The validation of the method, which was performed according to ICH guidelines (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) [1], comprises specificity, accuracy, linearity, precision, sensitivity and robustness. In addition, the results of an actual tablet sample analysis obtained by this CE method are statistically shown to be in close agreement with those obtained by an ion chromatographic method. |
| |
Keywords: | Topiramate Sulfate Sulfamate |
本文献已被 ScienceDirect 等数据库收录! |
|