HPLC法测定盐酸托哌酮片含量

Determination of tolperisone hydrochloride tablets by HPLC

目的:建立用HPLC法测定盐酸托哌酮片含量的方法。方法:采用Phenomenex Luna C_(18)柱(250 mm×4.6 mm,5μm),以乙腈-0.1 mol/L乙酸钠溶液(25:75)(用冰醋酸调节pH值至3.5)为流动相,流速为1.2 mL/min,检测波长261 nm。结果:盐酸托哌酮在20.2～202.0μg/mL浓度范围内与峰面积线性关系良好(r =0.999 99),平均回收率99.9%,RSD=0.6%。结论:本法操作简便,快速准确,专属性强,结果重现性好,可作为盐酸托哌酮片质量控制方法。

Objective： To establishe a HPLC method for determination of tolperisone hydrochloride tablets. Methods： A Phenomenex Luna C18 column（250 mm×4.6mm, 5μm）was used,the mobile phases was consisted of acetonitrile -0. 1 mol/L sodium acetate （25 ： 75）（adjust pH to 3.5 with acetic acid glacial） ,the flow rate was 1.2mL/min,the detector wavelength was at 261 nmo Results： The linear range was 20.2 - 202.0μg/mL （ r = 0.999 99）, the mean average recovery was 99.9% and RSD was 0.6% o Conclusion ： The method is simple, rapid and accurate. It can be used to quality control the tolperisone hydrochloride tablets.