LC-MS/MS法测定人血浆中辛伐他汀浓度

目的：建立测定人血浆中辛伐他汀浓度的LC-MS/MS测定方法,并研究辛伐他汀片在人体内的药代动力学。方法：血浆样品经乙酸乙酯萃取后,在正离子检测方式下选择多反应监测扫描方式进行质谱分析。结果：血浆中的内源性物质对样品测定无干扰,专属性良好。辛伐他汀的线性范围为0.1~10ng/mL,最低定量限为0.1ng/mL,平均提取回收率为81.4%,日内、日间精密度和准确度均符合生物样品分析的要求。测定的辛伐他汀片在人体内T1/2为（2.46±1.25）h;Tmax为（1.96±1.00）h;Cmax为（1.70±1.48）ng/mL;AUC0-24为（7.08±5.27）ng.h/mL;AUC0-∞为（8.11±5.83）ng.h/mL。结论：该方法操作简便、灵敏度高、重现性好,可以满足本实验低浓度药物测定及药代动力学研究。

Determination of Simvastatin in Human Plasma by LC-MS/MS

Objective：To develop a LC-MS/MS method for the analysis of simvastatin in human plasma,and the method would be used for pharmacokinetic study of simvastatin in human.Methods：simvastatin was extracted from plasma by ethyl ether and analyzed by MRM after protonted with ESI mode.Results：there were no endogenous material in plasma interfered with the determination.simvastatin in plasma can be determined by the established method over the range of 0.1~10ng·mL-1,and the LLOQ is 0.1 ng·mL-1.The recovery of this method is 81.4%.The accuracy,intra and inter day variances are consistent with the desire of biological specimen＇s analytic.Pharmacokinetic parameters of simvastatin in human are as follows：T1/2（2.46±1.25）h;Tmax（1.96±1.00）h;Cmax（1.70±1.48）ng/mL;AUC0-24（7.08±5.27）ng·h/mL;AUC0-∞（8.11±5.83）ng·h/mL.Conclusion：This method is convenient,sensitive and reproducible.It is suitable for determination of low concentration drug and the demand of pharmacokinetic and bioequivalence study.