中文摘要：

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。

英文摘要：

Objective To establish an HPLC method for the determination of the isomers of clopidogrel sulfate and Aspirin Tablets by UV detector. Methods The chromatography analysis was performed on a ULTRON ES-OVM（ 150 mm × 4. 6 mm,5 μm）. The mobile phase consisted of phosphate bufferacetionitrile（ volume ratio 75∶ 25） with flowrate at 1. 0 m L·min^-1. The wavelengths were 220 nm. Results The isomers and clopidogrel sulfate in compound preparations were well separated,and the resolution（ R）was more than 1. 5,Aspirin and other impurities do not interfere with the derermination of isomers. The test results have good reproducibility. Conclusions The method is simple,rapid,and highly sensitivite,which can be used to control the isomer in clopidogrel sulfate and aspirin tablets.