HPLC法测定盐酸曲美他嗪含量及有关物质

目的采用高效液相色谱法测定盐酸曲美他嗪原料的含量并建立有关物质的检查方法。方法采用C18色谱柱(4.6mm×250mm,5μm);以0.025mol.L-1磷酸二氢铵溶液-甲醇(80∶20)为流动相,检测波长为232nm,柱温为30℃,流速为1.0mL.min-1。结果在该色谱条件下,盐酸曲美他嗪浓度在0.12~0.71mg.mL-1(r=0.9999)范围内呈良好线性关系;检测限为0.12ng(S/N≥3)。结论所建立的方法灵敏、准确、简便,可作为盐酸曲美他嗪含量测定方法及有关物质的检查方法。

HPLC determination of trimetazidine hydrochloride and its related substances

OBJECTIVE To establish an HPLC method for the determination of trimetazidine hydrochloride and related substances.METHODS The separation and analysis was performed on a C18 column（4.6mm×250mm,5μm）.The mobile phase consisted of 0.025mol·L-1ammonium dihydrogen phosphate solution-methanol（80∶20）.The detection wavelength was 232nm and the chromatography was operated at 30℃,the flow rate was 1.0mL·min-1.RESULTS A good linear relationship was obtained in the trimetazidine hydrochloride concentration of 0.12～0.71mg·mL-1（r=0.9999）.The limit of detection was 0.12ng（S/N≥3）.CONCLUSION The proposed method was sensitive,accurate and simple,and can be used for the determination of trimetazidine hydrochloride and related substances.