HPLC法测定人血浆中艾美拉唑的浓度

Determination of Esomeprazole in Human Plasma by HPLC

目的:建立以高效液相色谱法测定人血浆中艾美拉唑浓度的方法。方法:血浆以乙腈沉淀蛋白,上清液与二氯甲烷混合离心后,取上层水相进样分析。其中,色谱柱为Zobax Rx-Sil柱,流动相为甲醇,流速为1·5mL·min-1,紫外检测波长为306nm,内标为非那西丁,柱温为28℃。结果:艾美拉唑检测浓度在0·05～4·0mg·L-1范围内与峰面积积分值线性关系良好(r=0·9997),日内RSD为2·04%～2·91%,最低检测限为0·05mg·L-1,平均回收率为95·80%。结论:本方法取样量小、操作快速简便、灵敏度高,可为进一步开展生物等效性研究奠定基础。

OBJECTIVE：To develop a HPLC method for the determination of esomeprazole in human plasma.METHODS： The plasma sample was extracted with dichloromethane, after centrifugation of the mixture of supernatant fluid and dichlormethane, the upper layer aqueous phase was taken for analysis.The separation was performed on Zobax Rx-Si column with mobile phase consisted of MeOH at a flow rate of 1.SmL · min^ -1.The detection wavelength was 306nm, the internal standard was phenacetin and the column temperature was 28℃ .RESULTS： The calibration curves were linear in the range of 0.05-4.0mg · L^-1 for esomeprazole（r = 0.999 7） .The intra- day RSD was 2.04--2.91%; the lowest detectable limit was 0.05mg ·L^-1 and the average recovery of esomeprazole was 95.80 %. CONCLUSION ： The method is rapid, simple, specific and sensitive, in which the sample needed for determination is small.It serves as a foundation for the bioequiavailability study of esomeprazole.