高效液相色谱-质谱联用法测定人血浆中非索非那定的浓度

Determination of Fexofenadine in human plasma by LC-MS/MS

目的:建立以高效液相色谱-质谱联用法测定人血浆中非索非那定浓度的方法。方法:以苯乙双胍为内标物,采用C18柱,流动相由乙腈及30 mmol/ml NH4Ac(含0.1%甲酸,0.01%三氟乙酸)组成,采用梯度洗脱程序,测定血浆中非索非那定浓度。结果:非索非那定在2.26～676.46 ng/ml线性关系良好(r=0.999 6,n=7),定量下限浓度为2.26 ng/ml,RSD为0.7%,高、中、低浓度测定的相对回收率分别为(109.9±1.7)%、(103.1±7.2)%和(101.5±13.4)%,日内RSD分别为2.1%、2.5%和9.8%,日间RSD分别为1.3%、5.7%和7.1%。结论:所建方法预处理简单﹑专属性强、灵敏度高,适合测定非索非那定的血药浓度。

Objective： To establish the LC-MS/MS method for the determination of fexofenadine in human plasma.Methods： Phenformin was used as internal standard.C18 column was used with the mobile phase of acetonitrile and 30 mmol/mlNH4Ac（containing 0.1% formic acid and 0.01% trifluoraceticacid）.The concentration of fexofenadine in human plasma was determined by the method of LC-MS/MS with gradient elution.Results： A linearity was obtained from 2.26 to 676.46 ng/ml of fexofenadine in human plasma with a good correlation coefficient（r=0.999 6,n=7）,with the quantitative lower limit was 2.26 ng/ml.RSD was 0.7%.The mean recoveries were（109.9±1.7）%,（103.1±7.2）% and（101.5±13.4）% respectively in the quality control samples of high,middle and low concentration.The RSD with in day and between day were 2.1%,2.5%,9.8%（n=5） and 1.3%,5.7%,7.1%（n=5）,respectively.Conclusion： The method can be applied to determine the fexofenadine concentration in plasma.