高效液相色谱法测定人血浆中法莫替丁浓度及药动学研究

Determination of famotidine concentration in human plasma by HPLC and its pharmacokinetics in healthy male volunteers

目的：建立人血浆中法莫替丁浓度的高效液相色谱测定方法,并用于药动学研究。方法：9名健康男性志愿者单剂量口服法莫替丁胶囊40 mg,给药后不同时间采集血样,1 mL血浆样品以乙酸乙酯提取,采用反相高效液相-二极管阵列检测器分离测定血浆中的法莫替丁浓度,以3P97程序计算其药动学参数。结果：法莫替丁检测浓度线性范围为12.5～400μg.L-1（r=0.999 6）,最低定量限为12.5μg.L-1。高、中、低浓度的方法回收率分别为98.98%,99.16%,104.49%,日内及日间RSD均小于15%。药动学研究表明,法莫替丁的药-时曲线符合一室模型。结论：本方法准确度好,灵敏度高、稳定、简便,适用于法莫替丁血药浓度测定及其药动学研究。

Objective：To establish an HPLC method for the determination of famotidine concentration in human plasma and the pharmacokinetic study of famotidine.Methods： The famotidine concentrations in human plasma from 9 healthy volunteers were determined by HPLC at various time points after administration with single oral dose of 40mg famotidine.The pharmacokinetics parameters were calculated by the 3P97 program.Results： Linear detection range of famotidine was at concentrations from 12.5 to 400μg·L-1（r=0.9996）.The minimum detectable concentration of famotidine was 12.5μg·L-1.The relative recoveries were 98.98%,99.16% and 104.49%.Both the intra-day and inter-day RSD were less than 15%.Conclusion： The method is sensitive,accurate,stable and simple,and is suitable for monitoring the blood concentration and for the pharmacokinetic study of famotidine in human.