目的 建立HPLC法测定人血清中氯吡格雷及其羧酸代谢物SR26334，研究硫酸氢氯吡格雷片在PCI术后患者体内的药动学情况。方法 采用CLC-ODS色谱柱（250 mm×4.6 mm，5 μm）；流动相：乙腈–0.1%甲酸溶液（60：40）；检测波长：235 nm；体积流量：1.0 mL/min；柱温：40℃；进样体积10 μL。收集到7例PCI术后口服硫酸氢氯吡格雷片75 mg/d超过7 d的患者，在当天早上服药后0、0.5、1、1.5、2、3、4、6、8、12、16、24 h从静脉采血，检测氯吡格雷和SR26334的血药浓度，制备平均药时曲线，使用DSA 2.0计算氯吡格雷和SR26334的药动学参数。结果 氯吡格雷、SR26334在0.2~8 μg/mL线性关系良好，定量限均为0.2 μg/mL。绝对、相对回收率均大于80%，日内、日间精密度RSD值均小于5%。氯吡格雷、SR26334的C_max、t_max、t_1/2分别为（65±0.57）、（0.77±0.22）μg/mL，（3.02±0.69）、（2.88±0.48）h，（7.66±3.65）、（8.52±3.37）h。结论 本方法简便、快速，适用于硫酸氢氯吡格雷片血药浓度的临床监测。

Objective To establish an HPLC method for the determination of clopidogrel and its carboxylic acid (SR26334) in human serum, and study pharmacokinetics of Clopidogrel Sulfate Tablets in patients after PCI. Methods HPLC-UV method was adopted on CLC-ODS column (250 mm×4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1% formic acid solution (60:40). The detection wavelengths were 235 nm. The flow rate was 1 mL/min, and the column temperature was set at 40℃ with injection volume of 10 μL. Seven cases administered with Clopidogrel Bisulfate Tablets 75 mg/d more than 7 d after PCI were collected. After taking drugs in the morning, the blood samples were collected from venous blood after 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h, and the blood concentrations of clopidogrel and SR26334 were detected. The average time curve was prepared. The pharmacokinetic parameters of clopidogrel and SR26334 were calculated by DSA soft. Results A good linearity was shown in the concentration ranges of 0.2 — 8 μg/mL for clopidogrel and SR26334 with quantitative limits of 0.2 μg/mL. The absolute recovery and relative recoveries were all above 80%. The inter-day or intra-day precisions were less than 5%. C_max, t_max, and t_1/2 for clopidogrel and SR26334 were (65 ±0.57), (0.77 ±0.22) μg/mL, (3.02 ±0.69), (2.88 ±0.48) h, and (7.66 ±3.65), (8.52 ±3.37) h, respectively. Conclusion This method is simple and quick, which is suitable for clinical monitoring for the serum concentration of Clopidogrel Bisulfate Tablets.