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目的采用高效液相色谱法对复方制剂硫酸氢氯吡格雷阿司匹林片中氯吡格雷异构体进行测定。方法色谱柱为ULTRON ES-OVM(150 mm×4.6 mm,5μm)柱;流动相为浓度10 mmol·L-1H2O2缓冲溶液-乙腈(体积比为75∶25);流速为1.0 m L·min-1;采用紫外检测器,波长为220 nm。结果氯吡格雷与异构体能有效分离,分离度大于1.5且阿司匹林和其他杂质不干扰。结论该方法适用于该复方制剂中氯吡格雷的异构体控制。
OBJECTIVE To determine the clopidogrel isomers of the compound preparation clopidogrel bisulfate hydrogel by high performance liquid chromatography. Methods The column was ULTRON ES-OVM (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of 10 mmol·L-1 H2O2 buffer solution and acetonitrile (75:25 by volume). The flow rate was 1.0 m L · min- 1; UV detector with a wavelength of 220 nm. Results Clopidogrel and isomers can be effectively separated with resolution greater than 1.5 and no interference with aspirin and other impurities. Conclusion This method is suitable for the isomer control of clopidogrel in this compound preparation.