人血浆中普伐他汀的LC-MS/MS测定法及药代动力学应用

Determination of Pravastatin in Human Plasma by LC-MS/MS and Its Pharmacokinetic Study

建立LC-MS/MS法测定人血浆中的普伐他汀浓度。以普伐他汀-d9为内标,采用电喷雾离子源负离子模式、多反应监测进行定量分析,普伐他汀的监测离子对为m/z 423.4→m/z 321.25,普伐他汀-d9的监测离子对为m/z 432.4→m/z 321.25。结果显示,普伐他汀在0.2~100.0 ng/ml内线性关系良好,方法回收率为69.83%~82.69%,批内RSD≤16.09%,批间RSD≤12.59%,无明显基质效应。并将本法应用于健康受试者单次口服1钠片的人体药代动力学研究。

A LC-MS/MS method was established for the determination of pravastatin in human plasma.The detection of the analyte and the internal standard(pravastatin-d9)were conducted under negative ionization mode with an electrospray ionization interface.A multiple reaction monitoring mode was chosen with the transitions of m/z 423.4→m/z 321.25(pravastatin)and m/z 432.4→m/z 321.25(pravastatin-d9).The results showed that it was linear for the pravastatin in ranges of 0.2-100.0 ng/ml.The recoveries were 69.83%-82.69%,and the intra-and inter-day precisions were below 16.09%and 12.59%respectively.There was no significant matrix effect.And this method was applied to the human pharmacokinetic study of a single oral administration of pravastatin sodium tablets in healthy subjects.