HPLC-ELSD法测定托吡酯及其制剂的含量

HPLC-ELSD determination of topiramate and its preparations

目的:建立 HPLC-ELSD 法测定托吡酯及其制剂含量。方法:色谱柱为 Waters C_(18)柱(3.9 mm×150 mm,5 μm);流动相:甲醇-水(35:65);流速:1.0 mL·min^(-1);柱温35℃;蒸发光散射检测器 Alltech ELSD 2000D 的检测条件:气化温度:100℃,气体流量:2.8 L·min^(-1)。结果:托吡酯的线性范围为0.4～2.0 mg·mL^(-1)(r=0.9983),平均回收率为100.1%。结论:本法简便、快速,结果准确,重复性好,适用于托吡酯及其制剂的质量控制。

Objectlve：To establish a method for the quality analysis of topiramate and its preparations. Methods： The chromatorgraphic conditions was following ： Waters ClS column （ 3.9 mm× 150 mm, 5μm ）, the mobile phase was composed of methanol- water（35： 65） ,flow rate was at 1.0 mL. min-1 ,column temprature was 35℃ ,AUtech ELSD 2000D conditions was following ：drift tube was at 100℃ ,flow rate of the gas was 2. 8 L· min^-1. Results：A linearity and correlation coefficient were yielded from 0. 4 to 2. 0 mg · mL^-1 （ r = 0. 9983 ）. The mean recovery of topiramate was 100. 1%. Conclusion：The method is accurate, rapid and simple. It can be applied to the quality control of topiramate and its preparations.