RP-HPLC法测定埃索美拉唑镁的含量及有关物质

RP-HPLC Determ Ination of Esomeprazole Magnesium and Its Related Substances

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 an RP-HPLC method to determine the related substances of esomeprazole magnesium and its content. Methods The assay was conducted on an Agilent C18( 150 mm ×4. 6 mm,5 μm) with acetonitrile-phosphate buffer( adjusted to pH 7. 6 by phosphate acid)( 25∶ 75) as mobile phase at the flow rate of 1. 0 mL·min- 1,the detection wavelength was 280 nm. The column temperature was room temperature and the injection volume was 10mL. Results Esomeprazole magnesium completely separated from impurities. The linear concentration range of esomeprazole magnesium was 60 ~ 140μg / mL with the correlation coefficient of 0. 9995. The detection limit was 0. 05μg / mL. The average recovery rate was 102. 03%,and the RSD was 1. 5%. Conclusion The method is simple,sensitive and reproducible,the results are accurate and reliable. It may be applicable for the quality control of esomeprazole magnesium and its related substances.