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目的:建立高效液相色谱法测定硫酸氯吡格雷片中氯吡格雷含量的方法。方法:采用 Hypersil C_(18)(300mm×4.6mm,5μm)色谱柱,乙腈-0.01 mol·L~(-1)磷酸二氢钠(65:35,磷酸调 pH 至3)为流动相,检测波长235nm,流速1.0ml·min~(-1),进样量20μl。结果:在15~150μg·ml~(-1)范围内线性关系良好(r=0.999 6),平均回收率为100.5%,RSD 为1.0%(n=4)。结论:该法操作简便,灵敏,准确度高,可作为氯吡格雷质量控制的方法。
Objective: To establish a method for the determination of clopidogrel in clopidogrel sulfate tablets by high performance liquid chromatography. Methods: Hypersil C18 (300 mm × 4.6 mm, 5 μm) column was used as the mobile phase. The mobile phase was acetonitrile-0.01 mol·L -1 sodium dihydrogen phosphate (65:35, adjusted to pH 3 with phosphoric acid) Wavelength of 235nm, the flow rate of 1.0ml · min ~ (-1), injection volume 20μl. Results: The linear relationship was good (r = 0.999 6) in the range of 15-150 μg · ml -1. The average recovery was 100.5% and the RSD was 1.0% (n = 4). Conclusion: The method is simple, sensitive and accurate and can be used as a quality control method for clopidogrel.