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目的:建立以反相高效液相色谱法测定埃索美拉唑镁原料药的有关物质及含量的方法。方法:采用Agilent C18柱(150 mm×4.6 mm,5μm),以磷酸盐缓冲液(pH=7.6)-乙腈(75∶25)为流动相,流速为1.0 mL/min,检测波长为280 nm,柱温为室温,进样量为10μL。结果:主峰能与相邻杂质峰较好分离。埃索美拉唑镁在60~140μg/mL范围内呈良好的线性关系;检出限为1 ng/mL。埃索美拉唑镁平均加样回收率为102.03%;RSD为1.5%。结论:该方法准确,简便,灵敏,重复性好,可用于埃索美拉唑镁原料药有关物质及含量的测定以及质量控制。
Objective: To establish a method for the determination of related substance and content of esomeprazole magnesium raw material by reversed-phase high performance liquid chromatography. METHODS: The mobile phase consisted of an Agilent C18 column (150 mm × 4.6 mm, 5 μm) with phosphate buffer (pH = 7.6) and acetonitrile (75:25) at a flow rate of 1.0 mL / min and a detection wavelength of 280 nm. The column temperature was room temperature and the injection volume was 10 μL. Results: The main peak can be better separated from adjacent impurity peaks. Esomeprazole magnesium showed a good linearity in the range of 60-140 μg / mL with a detection limit of 1 ng / mL. The average recovery rate of esomeprazole magnesium was 102.03%; RSD was 1.5%. Conclusion: The method is accurate, simple, sensitive and reproducible. It can be used for the determination of the related substances and contents of esomeprazole magnesium raw materials and the quality control.