LC-MS/MS 法测定人血浆中伊伐布雷定浓度及药动学

目的:建立人血浆中伊伐布雷定的液相色谱-质谱-质谱联用测定方法,研究健康人体药代动力学.方法:以地西泮为内标物,采用液相色谱-质谱-质谱联用法,电喷雾电离源选择性正离子峰检测.测30名健康志愿者单剂量口服盐酸伊伐布雷定片的体内血药浓度,获得药动学参数.结果:伊伐布雷定在0.101-101 ng·mL-1浓度范围内呈良好的线性关系(r=0.998),最低检测浓度为0.101 ng·mL-1.高、中、低浓度的方法提取回收率分别为93.2%、86.6%、87.5%,日内、日间精密度RSD均小于15%.结论:LC-MS/MS方法灵敏度高,专属性强,准确,简便,适用于盐酸伊伐布雷定片的人体药代动力学研究.

Determination of Ivabradine in Human Plasma by LC-MS/MS and Study of Pharmacokinetics

Objective: To determine ivabradine in human plasma by a LC/MS/MS method, and to investigate its pharmacokinetics. Methods: Ivabradine concentrations in plasma were determined by LC-MS/MS. The test and reference formulations of ivabradine were given to 30 healthy male volunteers. Results: The linear range for rosuvastatin was 0.101-101 ng·mL-1(r = 0.998). The quantitation limit for rosuvastatin was 0.101 ng·mL-1. The draw recovery rates were 93.2 %, 86.6 % and 87.5 %, and RSD for intra-day and inter-day was both less than 15 %. Conclusion: LC-MS/MS method is sensitive, accurate and simple, and suitable for the study on pharmacokinetic of ivabradine in human.