HPLC法测定硫酸氯吡格雷片的含量

Delermination the Content of clopidogrel in clopidogrel sulfate tablets by HPLC

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 HPLC method for determination the content of clopidogrel in clopidogrel sulfate tablets, Method： the Hypersil C18 column（300 mm× 4.6 mm, 5 μm） was used, the acetonitrile - 0.01 tool· L^-1 sodium dihydrogen phosphate solution（65：35） （adjust pH to 3.0 with phosphoric acid） as mobile phase, the flow rate was 1.0 ml· min^-1 ,the detection wavelength was 235 nm. Result： The linear range of clopidogrel was 15-150 μg·ml^ -1 （ r = 0.999 6）, the average recovery was 100.5% with RSD 1.0% （n = 4）. Conclusion： The method is simple, sensitive and accurate, it can be used for quality control of the tablets.