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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(250×4.6 mm,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1 mL·min~(-1),柱温为25℃,检测波长为302 nm。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1.25,2.50 ng·mL~(-1),定量限分别为5.00,6.25 ng·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。
OBJECTIVE: To establish a HPLC-based gradient elution method for the determination of esomeprazole magnesium enteric-coated tablets. METHODS: Venusil XBP C18 column (250 × 4.6 mm, 5 μm) was used in this study. Acetonitrile-phosphate buffer (pH 7.6) -water (10:10:80) (pH7.6) -water (80:1:19) as mobile phase B at a flow rate of 1 mL · min -1 .The column temperature was 25 ℃ and the detection wavelength was 302 nm. Results: The separation of esomeprazole magnesium from impurities was good. The linear relationship between esomeprazole magnesium and impurity D was 0.50 ~ 5.02 and 0.50 ~ 4.96μg · mL ~ (-1), respectively. The detection limits were The average recoveries of esomeprazole magnesium and impurity D were 99.91% and 100.10% respectively (n = 1.25, 2.50 ng · mL -1, 5.00 and 6.25 ng · mL -1, respectively) = 9). Conclusion: The method is simple, accurate, sensitive and specific. It is suitable for the determination of esomeprazole magnesium enteric-coated tablets.