论文部分内容阅读
目的:建立LC-MS/MS法测定人血浆中艾咪朵尔的浓度,并研究其在人体内的药动学特征。方法:血浆样品经固相萃取,以含0.1%乙酸的乙腈溶液-含0.1%乙酸的水溶液为流动相,XbridgeTMC18色谱柱进行分离,多反应方式检测,以DAS软件进行房室模型拟合,计算主要药动学参数。结果:在选定的LC-MS/MS条件下,艾咪朵尔与内标不受血浆中杂质的干扰,在0.2~500 ng.mL-1的范围内线性良好。本方法回收率为99.35%~108%,日内、批间RSD<15%。10名健康受试者口服200 mg盐酸艾咪朵尔片后的药-时数据符合一级吸收的二室模型。结论:本方法简便、快速、灵敏,适用于艾咪朵尔的临床药动学研究。
OBJECTIVE: To establish a LC-MS / MS method for the determination of amiloride in human plasma and study its pharmacokinetics in human. METHODS: Plasma samples were separated by solid phase extraction (SPE) using 0.1% acetic acid in acetonitrile with 0.1% acetic acid as the mobile phase. The separated samples were separated on a Xbridge TMC18 column and detected by multiple reaction. The main pharmacokinetic parameters. Results: Amidoter and internal standard were not disturbed by impurities in the plasma under selected LC-MS / MS conditions and were linear over the range of 0.2 to 500 ng.mL-1. The recovery rate of this method is 99.35% ~ 108%, intra-day and inter-period RSD <15%. Pharmacokinetic-time data of 10 healthy subjects after oral administration of 200 mg of Emimonium Hydrochloride coincided with a two-compartment model of primary absorption. Conclusion: The method is simple, rapid and sensitive and suitable for clinical pharmacokinetic study of Emidium.