中文摘要：

提出了简单、灵敏的测定药物及体液中硫酸氢氯吡格雷含量的荧光新方法。利用荧光法研究了硫酸氢氯吡格雷与茜素红的作用,基于在盐酸介质中硫酸氢氯吡格雷能与茜素红形成离子对化合物,该化合物能被二氯甲烷萃取,当用428nm波长激发时在550nm左右能发射较强的荧光。因荧光强度与硫酸氢氯吡格雷浓度在一定范围内存在定量关系,从而建立了测定硫酸氢氯吡格雷含量的新方法。当盐酸溶液的浓度为0.3mol·L-1时,形成的离子对比较稳定,硫酸氢氯吡格雷浓度在1.0~11.0μg·mL-1范围内时离子对荧光强度与硫酸氢氯吡格雷浓度呈良好的线性关系,线性方程为F=53.32+35.01c(μg·mL-1),r=0.994,检出限为0.11μg·mL-1。硫酸氢氯吡格雷在药物和人血清、尿液中的回收率分别为90.6%~99.3%,104.6%~109.3%,96.3%~105.0%,干扰实验表明常用药物辅料对它的测定没有干扰。用本法测定了硫酸氢氯吡格雷片、人血清及尿样中硫酸氢氯吡格雷含量,结果令人满意。实验结果表明本法快速,灵敏度高,准确度好,可用于实际样品中硫酸氢氯吡格雷含量的测定。

英文摘要：

A simple and sensitive spectrofluorimetric method has been developed for the determination of clopidogrel sulfate in pharmaceutical formulation and human urine/serum .It is based on the formation of ion-pair complex between clopidogrel sulfate and alizarin red in 0.3 mol · L -1 hydrochloric acid solution .The ion pair complex was extracted in dichloromethane and the fluo-rescence intensity was measured at 550 nm after excitation at 428 nm .The various factors influencing ion-pair complex formation and fluorescence determination were discussed .Under the optimized conditions ,the fluorescence value showed a good linear rela-tionship with the clopidogrel sulfate concentration ranging from 1 .0 to 11.0 μg · mL -1 .The equation of calibration curve was F=53.32+35.01c(μg · mL -1 ) ,r= 0.994 ,and the detection limit was found to be 0.11 μg · mL -1 .No interference was ob-served from common co-existing substances or pharmaceutical excipient .The determination recoveries of clopidogrel sulfate in pharmaceutical formulation and human urine/serum samples were 90.6% ~99.3% ,104.6% ~109.3% ,96.3% ~105.0% ,re-spectively .The method was successfully applied to detect clopidogrel sulfate in clopidogrel sulfate tablet and human urine/ser-um .The obtained results of clopidogrel sulfate tablet were in good agreement with the results of HPLC .Therefore ,it is conclu-ded that the proposed method is simple ,sensitive and rapid for the determination of clopidogrel sulfate in real samples .