高效液相色谱-串联质谱法测定人血浆中的缬沙坦  

Determination of valsartan in human plasma by HPLC-MS/MS

作　　者：刘雪松[1] 刘伟[2] 门金玉[2] 闫冬[2] 高静[2] 

机构地区：[1]辽宁中医药大学附属第二医院,沈阳110034 [2]沈阳亿灵医药科技有限公司,沈阳110179

出　　处：《中国新药杂志》2011年第14期1321-1324,共4页Chinese Journal of New Drugs

摘　　要：目的：建立灵敏、快速的高效液相色谱-串联质谱测定人血浆中缬沙坦浓度的方法,并用于人体药代动力学研究。方法：200μL的血浆样品经乙醚提取处理后,以乙腈-水-甲酸（70∶30∶0.2）为流动相,Diamonsil-C18柱分离,通过电喷雾离子源四极杆串联质谱,以多反应监测（MRM）的方式进行检测,选择监测离子反应为m/z436.3→291.2（缬沙坦）和423.1→207.1（氯沙坦）。结果：缬沙坦在2.120~5 300 ng.mL-1浓度范围内线性关系良好,定量限为2.120 ng.mL-1,日内、日间精密度（RSD）均≤9.0%,准确度在0.9%以内,缬沙坦和内标氯沙坦的回收率分别为83.1%和79.4%。结论：该法选择性强、灵敏度高,适用于缬沙坦的临床药动力学研究。Objective： To establish an HPLC-MS/MS method for the determination of valsartan in human plasma,and to investigate pharmacokinetics in human.Methods： Plasma samples treated with ether extraction were separated with a mobile phase of acetonitrile-water containing 0.2% formic acid（70∶30∶0.2）.The detection was carried out by means of electrospray ionization mass spectrometry in positive ion mode.Multiple reaction monitoring（MRM） mode was used with the transitions of m/z 436.3→291.2 for valsartan and m/z 423.1→207.1 for internal standard,respectively.Results： The calibration curve of valsartan was linear in the range of 2.120~5 300 ng·mL-1.The limit of quantification was 2.120 ng·mL-1.The extraction recovery of valsartan was 81.9%~84.8%.The RSDs of intra-and inter-day were less than 15.0%.Conclusion： The method is shown to be simple,accurate,sensitive and specific for the determination of valsartan in human plasma.

关 键 词：缬沙坦 高效液相色谱-串联质谱法 药代动力学 

分 类 号：R917[医药卫生—药物分析学]