高效液相色谱法测定埃索美拉唑镁肠溶片的有关物质

目的：建立高效液相色谱梯度洗脱法测定埃索美拉唑镁肠溶片的有关物质。方法：采用venusil XBP C₁₈色谱柱（250×4.6mm，5μm），以乙腈-磷酸盐缓冲液（pH7.6）-水（10：10：80）为流动相A，以乙腈-磷酸盐缓冲液（pH7.6）-水（80：1：19）为流动相B进行梯度洗脱，流速为1mL·min^-1，柱温为25℃，检测波长为302nm。结果：埃索美拉唑镁与杂质分离良好，埃索美拉唑镁、杂质D分别在0.50~5.02，0.50~4.96μg·mL^-1浓度范围内线性关系良好，检测限分别为1.25，2.50ng·mL^-1，定量限分别为5.00，6.25ng·mL^-1，埃索美拉唑镁与杂质D的平均回收率分别为99.91%，100.10%（n=9）。结论：该方法简便、准确、灵敏，专属性强，适用于埃索美拉唑镁肠溶片有关物质的测定。

Determination of related substances of esomeprazole magnesium enteric-coated pellets-type tablets by gradient HPLC

OBJECTIVE To establish an method for the determination of related substances of esomeprazole magnesium enteric-coated pellets-type tablets by gradient HPLC.METHODS The separation was performed on a Venusil XBP C₁₈ column (250 mm×4.6 mm, 5 μm), acetonitrile-phosphate buffered saline(pH7.6)-water(10:10:80) as mobile phase A, acetonitrile-phosphate buffered saline(pH7.6)-water(80:1:19) as mobile phase B. The flow rate was 1 mL·min^-1, the column temperature was 25℃, the detection wavelength was at 302 nm.RESULTS The esomeprazole magnesium and related substances could be baseline separated. The calibration curves of esomeprazole magnesium and impurity D were linear in the concentration ranges of 0.50-5.02 and 0.50-4.96 g·mL^-1. Their detection limit were 1.25 and 2.50 ng·mL^-1, and their limit of quantification were 5.00 and 6.25 ng·mL^-1, seperately. Their average recoveries were 99.91% and 100.10% (n=9).CONCLUSION This method is rapid, accurate, sensitive, and can be used for the determination of the related substances of esomeprazole magnesium enteric-coated pellets-type tablets.