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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。
Objective: To establish a method for the determination of simvastatin in human plasma by LC-MS / MS and study the pharmacokinetics of simvastatin in human. Methods: After plasma samples were extracted with ethyl acetate, multiple reaction monitoring scanning mode was selected for positive ion detection. Results: The endogenous substances in plasma had no interference with the sample determination and the specificity was good. The linear range of simvastatin was 0.1 ~ 10ng / mL, the lowest limit of quantification was 0.1ng / mL and the average recovery was 81.4%. The precision and accuracy of simvastatin all met the requirements of biological sample analysis. The measured values of simvastatin tablets were (2.46 ± 1.25) h in T1 / 2, 1.96 ± 1.00 h in Tmax and (1.70 ± 1.48) ng / mL in Cmax and (7.08 ± 5.27) ng in AUC0-24 .h / mL; AUC0-∞ was (8.11 ± 5.83) ng.h / mL. Conclusion: The method is simple, sensitive and reproducible, which can meet the low concentration of drug determination and pharmacokinetic studies.