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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。
Objective: To establish a liquid chromatography-mass spectrometry-mass spectrometry method for the determination of ivabradine in human plasma and study the pharmacokinetics of healthy human. Methods: With diazepam as internal standard, the selective positive ion peak of electrospray ionization source was detected by liquid chromatography-mass spectrometry-mass spectrometry. The plasma concentrations of ivabradine hydrochloride tablets in a single dose of 30 healthy volunteers were measured and the pharmacokinetic parameters were obtained. Results: The ivabradine was linear in the range of 0.101-101 ng · mL-1 (r = 0.998) with the lowest detection concentration of 0.101 ng · mL-1. The recoveries of high, medium and low concentration methods were 93.2%, 86.6%, 87.5%, respectively. The intra-day and inter-day RSDs were less than 15%. Conclusion: The LC-MS / MS method has high sensitivity, specificity, accuracy and convenience. It is suitable for human pharmacokinetics study of ivabradine hydrochloride tablets.