摘要:
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 C18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。
Abstract:
Objective: To establishe a HPLC method for determination of tolperisone hydrochloride tablets. Methods: A Phenome- nex Luna C~(18) column(250 mm×4.6 mm,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 nm。 Results: The linear range was 20.2~202.0μg,/mL(r=0.99999),the mean average recovery was 99.9% and RSD was 0.6%。 Conclusion: The method is simple,rapid and accurate.It can be used to quality control the tolperisone hydrochloride tablets.