高效液相色谱法测定人血浆中奥美拉唑浓度

Determination of Omeprazole in Human Plasma by HPLC

建立测定人血浆中奥美拉唑浓度的高效液相色谱法，并应用于人体药代动力学研究。血浆样品中加入内标非那西丁后用乙酸乙酯提取，色谱柱为Zorbax SB—C18柱，流动相为0．05mol·L^-1乙酸铵溶液（用氨水调至pH7．0）-乙腈（68：32），流速为1．0ml·min^-1，紫外检测波长302nm。血浆中内源性物质对样品测定无干扰。本方法线性范围为0．01～2μg·ml^-1（r=0．9997），最低定量浓度为0．01μg·ml^-1，提取回收率大于80％，方法回收率为98．6％～103．1％，日内、日间RSD均小于6％。本法简便、准确，适用于奥美拉唑药代动力学的研究。

A HPLC method for the determination of omeprazole in human plasma was established, and was used on the research of pharmacokinetics in healthy volunteers. After addition of phenacetin （ internal standard）, plasma samples was extracted with ethyl acetate and determined. A Zorbax SB - C18 column was used with the mobile phase of 0. 05mol·L^-1 ammonium acetate solution adjusted to pH 7.0 with concentrated ammonia） and acetonitrile （68： 32） with a flow rate of 1.0ml ·mol-1 The detection wavelength was at 302nm. The blank plasma did not interfere with the determination. The calibranon range was 0. 01 -2 μg·ml^-1 （r =0. 9997 ）, and the quantitative limit was 0. 01 μg·ml^-1. The extraction recovery was more than 80%, and the method recovery was 98.6% - 103. 1%. RSD of within - day and between - day were less than 6%. The method is simple and accurate, and suitable for the pharmacokinetic study of omeprazole.