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目的:建立以高效液相色谱法测定奥赛博司原料药中有关物质含量的方法。方法:色谱柱为SunFireTMRP C18,流动相为磷酸盐缓冲溶液(pH3.05)-乙腈(8∶2),流速为1mL.min-1,检测波长为220nm,进样量为20μL,柱温为室温。结果:3批原料药经破坏试验后奥赛博司主峰与其它杂质峰均分离较好,有关物质含量均小于1.19%。结论:本方法简便、灵敏度高,可用于奥赛博司有关物质的含量检测。
Objective: To establish a method for the determination of related substances in Orsay medicine by high performance liquid chromatography. Methods: The column was SunFire TMRP C18, the mobile phase consisted of phosphate buffer (pH3.05) -acetonitrile (8: 2), the flow rate was 1mL.min-1, the detection wavelength was 220nm, the injection volume was 20μL, Room temperature. Results: After the destructive tests, the main peaks of Orsay for three batches of raw materials were well separated from other impurities and the related substances were all less than 1.19%. Conclusion: The method is simple, sensitive and can be used for the determination of related substances in Orsay.