RPHPLC法测定盐酸曲美他嗪片的含量和有关物质

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

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Diamonsil^TM C18柱（200mm×4．6mm，5μm），以甲醇-0．03mol·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1．0mL·min^-1，检测波长为225nm。结果盐酸曲美他嗪在5～50mg·L^-1内线性关系良好，r=0．9999；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。

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 C18 column（200 mm × 4.6 mm, 5 μm）. The mobile phase was composed of methanol-0.03 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·mL^-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.