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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?g/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%。
A HPLC method was established for the determination of esomeprazole magnesium enteric-coated capsules. A mobile phase A was developed on an XBridge C18 column with acetonitrile: phosphate buffer (pH 7.6): water (10:10:80), acetonitrile: phosphate buffer (pH 7.6) As mobile phase B, gradient elution, detection wavelength of 302 nm. Esomeprazole magnesium and its related substances H118 / 87, H168 / 66, H431 / 41 and H193 / 61 were in the range of 0.04-2.0, 0.04-2.0, 0.04-2.0, 0.05-10.0 and 0.04-2.0 μg / ml, respectively The average recoveries were 99.5%, 96.7%, 99.8%, 98.9% and 99.3%, respectively, with RSDs of 0.45%, 0.20%, 0.78%, 0.43% and 0.41%, respectively.