α_1-酸性糖蛋白手性固定相测定埃索美拉唑钠中对映异构体杂质的含量

Determination of Enantiomer Impurity in Esomeprazole Sodium by α_1-Acidglycoprotein Chiral Column

目的:采用α_1-酸性糖蛋白手性固定相高效液相色谱法测定埃索美拉唑钠原料药中对映异构体杂质的含量。方法:采用CHIRAL-AGP手性固定相柱(150 mm×4 mm,5μm);检测波长:302 nm;流动相:磷酸盐(0. 01 mol·L^(-1),pH 6. 0)-乙腈(17∶3);流速:0. 8 ml·min^(-1);柱温:25℃;进样量:20μl。结果:埃索美拉唑钠与其对映异构体能够完全分离,对映异构体在0. 08～0. 40μg·ml^(-1)范围内线性关系良好(r=0. 999 8),加样回收率为100. 4%(RSD=1. 02%,n=9)。结论:该方法快速、准确,可用于埃索美拉唑钠原料药中对映异构体杂质含量的测定。

Objective: To determine the content of enantiomer impurity in esomeprazole sodium by α1-acidglycoprotein chiral column. Methods: A CHIRAL-AGP chiral stationary phase column (150 mm × 4 mm,5 μm) was used,the detection wavelength was302 nm,the mobile phase was phosphate (0. 01 mol·L-1,pH 6. 0)-acetonitrile (17 ∶ 3),the flow rate was 0. 8 ml·min-1,the column temperature was 25 ℃ and the injection volume was 20 μl. Results: Esomeprazole sodium and its enantiomer impurity could be separated completely. The calibration curve was linear within the range of 0. 08-0. 40 μg·ml-1 (r = 0. 999 8). The recovery was 100. 4% (RSD = 1. 02%,n = 9). Conclusion: The present method is rapid and simple,and can be used to determine the content of enantiomer impurity in esomeprazole sodium.