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LC-MS/MS法测定人血浆中辛伐他汀浓度

Determination of Simvastatin in Human Plasma by LC-MS/MS
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摘要 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 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.
出处 《辽宁中医药大学学报》 CAS 2011年第10期30-32,共3页 Journal of Liaoning University of Traditional Chinese Medicine
基金 国家自然基金项目(81001633) 天津市自然基金项目(11JCYBJC14800)
关键词 LC-MS/MS 辛伐他汀 药代动力学 LC-MS/MS simvatatin pharmacokinetics
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