维C银翘片中马来酸氯苯那敏含量测定方法的优化

Improvement on Determination of Chlorphenamine Maleate in Vitamin C Yinqiao Tablets

目的:优化维C银翘片中马来酸氯苯那敏含量测定方法。方法:采用反复萃取(药典法)和直接超声两种提取方法,比较马来酸氯苯那敏的含量测定结果。结果:反复萃取法步骤繁琐,污染环境,其回收率仅为91.4%,含量为116%;直接提取法简单,环境友好,其回收率为100.3%,含量为131%。二极管阵列检测结果表明优化后的方法色谱峰纯度符合要求。结论:优化方法适用于控制维C银翘片中马来酸氯苯那敏的质量,实验数据提示,维C银翘片的质量问题需要密切关注。

Objective： To improve the determination method of ehlorphenamine maleate in Vitamin C Yinqiao tablets by HPLC. Meth- ods： Chlorphenamine maleate was determined by HPLC after the Vitamin C Yinqiao tablets were pretreated through repeatedly extraction or simply ultrasonic processing, and chromatography determination conditions were optimized. Results：The repeatedly extraction method was strenuous and environment-hazardous, with the recovery of 91.4% and the tablets content of 116%. The ultrasonic processing method was simple, environment-friendly, and more reliable, with the recovery of 1130. 3% and the tablets content of 131%. The purity of the chromatographic peak was verified by diode-array detector. Concluslon：The improved method is appropriate for the quality control of ehlorphenamine maleate in Vitamin C Yinqiao tablets, and we should pay close attention to the quality of Vitamin C Yinqiao tablets.