RPHPLC法测定盐酸曲美他嗪片的含量和有关物质

目的建立测定盐酸曲美他嗪片的含量和有关物质的RP HPLC法。方法色谱柱为Diamon-silTMC18柱(200 mm×4.6 mm,5μm),以甲醇0.03 mol.L-1磷酸二氢钾溶液(体积比为15∶85,pH=3.0)为流动相,流速为1.0 mL.min-1,检测波长为225 nm。结果盐酸曲美他嗪在5~50 mg.L-1内线性关系良好,r=0.999 9;平均回收率为100.4%,RSD为1.6%;检出限为25μg.L-1;有关物质各杂质峰与主峰之间的分离良好。结论该测定方法可作为盐酸曲美他嗪的含量测定方法,以控制其原料及制剂的质量。

RP-HPLC determination of trimetazidine dihydrochloride and its related substances in tablets

Objective To develop an RP-HPLC method for the determination of the contents of trimetazidine dihydrochloride and its related substances in tablets.Methods The separation was performed on a Diamonsil~(TM) C_(18) column(200 mm×4.6 mm,5 μm).The mobile phase was composed of methanol0.03 mol·L~(-1) potassium dihydrogen phosphate(pH=3.0)(15∶85,V/V).The flow rate was 1.0 mL·min~(-1)and the determination wavelength was set at 225 nm.Results A linearity between peak areas and trimetazidine dihydrochloride concentrations was achieved in the range of 5～50 μg·mL~(-1),with r=0.999 9.The average recovery was 100.4%,with an RSD of 1.6%.The detection limit was 25 μg·L~(-1).Conclusions The method is simple,rapid,accurate and sensitive,and can be used for the assay and quality control of trimetazidine dihydrochloride in the tablets.