HPLC法测定盐酸曲美他嗪缓释片中有关物质

Determination of related substances in Trimetazidine Dihydrochloride Modified Release Tablets by RP-HPLC

目的建立盐酸曲美他嗪缓释片中有关物质的高效液相色谱测定方法。方法采用Diamonsil C18色谱柱(250mm×4.6 mm,5μm),流动相为0.012 mmol/L庚烷磺酸钠溶液(p H 3.5)–甲醇–乙腈(55∶36∶9),体积流量为1.0 m L/min,柱温为30℃,检测波长为210 nm,进样量:20μL。结果在所选定的液相色谱条件下,有关物质与主药分离良好。盐酸曲美他嗪、杂质A、杂质B和杂质C的检出限分别为10.2、4.4、4.5、8.0 ng。结论该方法操作简单,重复性好,专属性强,可用于控制盐酸曲美他嗪缓释片中的有关物质。

Objective To establish an RP-HPLC method for the determination of related substances in Trimetazidine Dihydrochloride Modified Release Tablets. Methods The separation was performed on a Diamonsil C18 column（250 mm×4.6 mm, 5 μm） with the mobile phase of 0.012 mmol/L heptane sulfonic acid sodium solution（p H 3.5）- methanol- acetonitrile（55∶36∶9）. The flow rate was 1.0 m L/min with injection volume of 20 μL, the temperature of column was set 30 ℃, and the detection wavelength was set at 210 nm. Results Trimetazidine dihydrochloride and its related substances could be completely separated under the conditions. The detection limits of trimetazidine dihydrochloride, impurities A, B, and C were 10.2, 4.4, 4.5, and 8 ng. Conclusion The method is simple, quick, accurate, and reliable, which can control the related substances in Trimetazidine Dihydrochloride Modified Release Tablets.