高效液相色谱法测定保泰松片的有关物质

HPLC determination of related substances of phenylbutazone tablets

目的建立测定保泰松片有关物质的高效液相色谱法。方法采用Phenomenex Luna C18(250mm×4.6mm,5μm)色谱柱,流动相为乙腈-水(磷酸调p H至3.0)(50∶50),检测波长为239nm,流速1.0m L/min,柱温为30℃,进样体积为10μL。结果在选定的色谱条件下,主成分能与杂质峰之间分离度良好;方法的检测限为0.2μg/m L;供试品溶液在8h内稳定性良好。结论本方法简单,准确,重现性好,可用于保泰松片的有关物质检查。

Objective To establish a HPLC method for the determination of related substances of phenylbutazone tablets. Methods A Phenomenex Luna C18 column（250mm×4.6mm,5μm） was used, and the mobile phase was acetonitrile–water[adjusting p H to 3.0 with phosphoric acid]（50：50）.The flow rate was 1.0 m L/min and the detection wavelength was set at 239 nm.The column temperature was set at 30℃ and the injection volume was 10 μL. Results Related substances were completely separated from the main constituent.The limit of detection was 0.2μg/m L.The sample solution was stable within 8h.Conclusion The method wsa simple,accurate with good reproducibility,and can be used in the determination of related substances of phenylbutazone tablets.