HPLC法测定埃索美拉唑镁肠溶胶囊的有关物质

Determination of related substances in esomeprazole magnesium enteric-coated capsules by HPLC

应用HPLC法测定了埃索美拉唑镁肠溶胶囊的有关物质。采用Welch C18色谱柱（150×4.6 mm,5μm）,采用乙腈-磷酸盐缓冲液（p H 7.6）-水梯度洗脱,流速为1.0 m L/min,柱温30℃,检测波长为302 nm。埃索美拉唑镁和奥美拉唑磺酰化物分别在0.08-8.0μg/m L（r=0.9999）和0.224-22.4μg/m L（r=1）范围内线性关系良好;奥美拉唑磺酰化物的平均回收率（n=9）为99.5%,RSD为1.6%;测定的4批样品,奥美拉唑磺酰化物、其它单杂和总杂含量均符合规定。方法适用于埃索美拉唑镁肠溶胶囊有关物质的测定。

To establish an HPLC method for related substances determination of esomeprazole magnesium entericcoated capsules. The determination was carried out on a column of Welch C18（ 150 × 4. 6 mm,5 μm）. The mobile phase consisted of a mixture of acetonitrile,phosphate buffer（ p H 7. 6） and water by gradient elution,with a flow rate of 1 m L / min at 30℃. The detection wavelength was 302 nm. The calibration curves were linear in the range of 0. 08 - 8. 0 μg / m L（ r = 0. 9999） for esomeprazole magnesium,0. 224 - 22. 4 μg / m L（ r = 1） for omeprazole sulfone. The average recovery（ n = 9） of omeprazole sulfone was 99. 5%,RSD was 1. 6%. The contents of omeprazole sulfone,any other individual impurity and total impurities were acceptable for all 4batches. This method showed good precision,high accuracy,could be applied to the related substances determination in esomeprazole magnesium enteric-coated capsules.