HPLC法测定复方硫酸氢氯吡格雷片中硫酸氢氯吡格雷和阿司匹林的含量

目的建立复方硫酸氢氯吡格雷片中硫酸氢氯吡格雷和阿司匹林含量测定的HPLC法。方法色谱柱为氰基柱,流动相为甲醇-水-三乙胺(体积比为500∶500∶2,磷酸调节pH值至3.8),流速为1 mL.min-1,检测波长为235 nm,柱温为35℃,进样量为20μL。结果在该色谱条件下,硫酸氢氯吡格雷与阿司匹林可达到较好分离,硫酸氢氯吡格雷在12.0~100.0 mg.L-1内质量浓度与峰面积呈良好的线性关系(r=0.999 5)。阿司匹林在38.4~320.0 mg.L-1内质量浓度与峰面积呈良好的线性关系(r=0.999 7)。硫酸氢氯吡格雷与阿司匹林的平均回收率分别为(99.7±1.80)%(n=9)和(100.3±0.53)%(n=9)。结论HPLC法适用于复方硫酸氢氯吡格雷片中硫酸氢氯吡格雷和阿司匹林的含量测定。

Determination of the content of the compound clopidogrel bisulfate tablets by HPLC

Objective To establish a method for the determination of the content of compound clopidogrel bisulfate tablets. Methods The determination was performed with CN-3 as the chromatographic column. The mobile phase consisted of methanol-water- triethylamine (V/V/V = 500∶500∶2, adjusted pH to 3.8 by phosphoric acid )with a flow rate of 1 mL·min-1; the detection wave length was 235nm; the column temperature was 35℃, and the sample size was 20μL.Results clopidogrel bisulfate could be well separated from aspirin under the conditions mentioned above. The linear relationship between the concentration and area of chromatographic peak were established in the rang of 12～100 mg·L-1 for clopidogrel bisulfate and in the range of 38.4～320.0 mg·L-1 for aspirin. The average recoveries of clopidogrel bisulfate and aspirin were 99.7 ± 1.80 % and 100.3 ± 0.53 % (n = 9), respectively. Conclusions The method is easy, exclusive, accurate and suitable for the determination of the content of compound clopidogrel bisulfate tablets.