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428 nm波长激发时在550 nm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0.3 mol·L-1时, 形成的离子对比较稳定, 硫酸氢氯吡格雷浓度在1.0～11.0 μg·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0.11 μg·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。

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 fluorescence 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 relationship 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 observed 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%, respectively. The method was successfully applied to detect clopidogrel sulfate in clopidogrel sulfate tablet and human urine/ serum. The obtained results of clopidogrel sulfate tablet were in good agreement with the results of HPLC. Therefore, it is concluded that the proposed method is simple, sensitive and rapid for the determination of clopidogrel sulfate in real samples.