Helali N, Tran N T, Monser L, Taverna M
Institut National des Sciences Appliquées et de Technologie, Laboratoire de Chimie Analytique et Electrochimie 04UR12-01, Centre Urbain Nord, B.P. No. 676, 1080 Tunis Cedex, Tunisia.
Talanta. 2008 Jan 15;74(4):694-8. doi: 10.1016/j.talanta.2007.06.036. Epub 2007 Jul 1.
A simple and rapid capillary zone electrophoresis (CZE) method with UV detection has been developed for the determination of famotidine and its potential impurities in pharmaceutical formulations. The electrophoretic separation of these compounds was performed using a fused silica capillary and 37.5mmolL(-1) phosphate buffer pH 3.5 as the electrolyte. Under the optimised conditions, six impurities could be resolved from the famotidine peak in less than 7min. The calibration curves obtained for the seven compounds were linear over the concentration range investigated (from 1.5 to 78.5microg mL(-1)). The intra- and inter-day relative standard deviations for the migration times and corrected peak areas were less than 2% and 5%, respectively. The detection limits were found to be 0.09microg mL(-1) for famotidine, and from 0.1 to 0.62microg mL(-1) depending on the impurities. The method has been successfully applied to the determination of famotidine in commercial dosage forms.
已开发出一种采用紫外检测的简单快速毛细管区带电泳(CZE)方法,用于测定药物制剂中法莫替丁及其潜在杂质。这些化合物的电泳分离是使用熔融石英毛细管和37.5mmolL(-1)pH 3.5的磷酸盐缓冲液作为电解质进行的。在优化条件下,不到7分钟即可从法莫替丁峰中分离出六种杂质。在所研究的浓度范围(1.5至78.5μg mL(-1))内,七种化合物获得的校准曲线呈线性。迁移时间和校正峰面积的日内和日间相对标准偏差分别小于2%和5%。发现法莫替丁的检测限为0.09μg mL(-1),杂质的检测限为0.