埃索美拉唑镁肠溶胶囊有关物质的HPLC法测定

Determination of Related Substances in Esomeprazole Magnesium Enteric-coated Capsules by HPLC

建立了高效液相色谱法测定埃索美拉唑镁肠溶胶囊的有关物质.采用XBridge C18色谱柱,以乙腈∶磷酸盐缓冲液（pH 7.6）∶水（10∶10∶80）为流动相A,乙腈∶磷酸盐缓冲液（pH 7.6）∶水（80∶1∶19）为流动相B,梯度洗脱,检测波长302 nm.埃索美拉唑镁及其有关物质H118/87、H168/66、H431/41和H193/61分别在0.04～2.0、0.04～2.0、0.04～2.0、0.05～10.0和0.04～2.0 μg/ml范围内线性关系良好;平均回收率分别为99.5％、96.7％、99.8％、98.9％和99.3％,RSD分别为0.45％、0.20％、0.78％、0.43％和0.41％.

An HPLC method was established for the determination of the related substances in esomeprazole magnesium enteric-coated capsules.An XBridge C18 column was used with the mobile phase of acetonitrile ∶ pH 7.6 phosphate buffer ∶ water （10 ∶ 10 ∶ 80,A） and acetonitrile ∶ pH 7.6 phosphate buffer ∶ water （80 ∶ 1 ∶ 19,B） by gradient elution,at the detection wavelength of 302 nm.The calibration curves were linear for esomeprazole magnesium and its related substances,H118/87,H168/66,H431/41 and H193/61,in the ranges of 0.04-2.0,0.04-2.0,0.04-2.0,0.05-10.0 and 0.04-2.0 μg/ml.Their average recoveries were 99.5 ％,96.7 ％,99.8 ％,98.9 ％ and 99.3 ％,with RSDs of 0.45 ％,0.20％,0.78 ％,0.43 ％ and 0.41％,respectively.