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目的:建立LC-MS/MS法测定人血浆中盐酸依伐布雷定浓度,并用于药动学研究。方法:血浆经乙醚萃取处理,盐酸多奈哌齐为内标,采用氰基柱,以甲醇:0.3%甲酸水溶液(40:60)为流动相,流速0.3 ml·min~(-1),以ESI源正离子,多反应检测方式监测,选择离子反应为m/z469.0→177.0(盐酸依伐布雷定),m/z 380.5→243.3(内标)。结果:盐酸依伐布雷定在0.05～100 ng·ml~(-1)浓度范围内线性关系良好,低、中、高三种浓度平均提取回收率分别为70.87%、76.88%、78.31%,日内、日间相对标准差均小于15%。结论:该法可以用于盐酸依伐布雷定的药动学研究。
Objective: To establish a LC-MS / MS method for the determination of vvaribradine hydrochloride in human plasma and to study its pharmacokinetics. Methods: The plasma was extracted with ether and donepezil hydrochloride was used as the internal standard. The column was equipped with a mobile phase of methanol and 0.3% formic acid (40:60) with a flow rate of 0.3 ml · min ~ (-1) Ion and multi-reaction detection. The selected ion reaction was m / z 469.0 → 177.0 (valeratebine hydrochloride) and m / z 380.5 → 243.3 (internal standard). Results: The results showed that there was a good linear relationship between the concentration of valafradine hydrochloride and the concentration of 0.05 ~ 100 ng · ml ~ (-1), and the average recoveries of low, medium and high concentrations were 70.87%, 76.88% and 78.31% The relative standard deviations during the day were less than 15%. Conclusion: This method can be used for the pharmacokinetics of valeratibine hydrochloride.