高效液相色谱法测定人血浆中西洛他唑药物浓度及药动学研究

目的建立高效液相色谱法测定人血浆中西洛他唑的浓度,并研究其在健康人体内的药动学。方法采用C18反相色谱柱,以乙腈-水(0.1%甲酸)(65∶35)为流动相等度洗脱,流速为1.0 mL·min-1;检测波长为257 nm;进样量为20μL。结果西洛他唑在0.05～10 mg·L-1范围内线性关系良好(r=0.999 8),各样品的提取回收率均大于80%,日内、日间精密度RSD均小于10%。西洛他唑的血药经时过程符合一级吸收的二室模型,其主要药动学参数:tmax:2.94±1.21 h;Cmax:(0.99±0.12)mg·L-1;AUC(0-t):(9.57±1.31)mg·h-1.L-1。结论该方法方便快捷,专属性强,准确可靠,适用于西洛他唑的临床药动学研究。

Determination of cilostazol in human plasma by HPLC and its pharmacokinetics

Objective To develop an HPLC detection for the quantification of cilostazol in human plasma and to study the pharmacokinetics.Methods A C18 Column was used.The mobile phase consisted of acetonitrile-water（0.1% formic acid）（65：35） with isocratic elution.Results The calibration curve was linear within 0.05 ～ 10 mg.L-1（r =0.999 8）.The recoveries were more than 80%,with the intraday-and interday-RSDs less than 10%.The blood plasma cot curve of cilostazol conformed to two compartments model of the first order absorption.The main pharmacokinetic parameters were tmax：（2.94 ± 1.21） h;Cmax：（0.99 ± 0.12） mg.L-1;AUC（0-t） ：（9.57 ± 1.31） mg.h-1.L-1.Conclusion The method is proved to be convenient,rapid,accurate and specific and has been successfully applied to clinical pharmacokinetics.