高效液相色谱法测定氟曲马唑含量和有关物质

HPLC determination of flutrimazole and its related substances

目的:建立氟曲马唑的HPLC测定法及有关物质检查方法。方法:采用大连依利特C18(250mm×4.6mm,5μm)色谱柱,流动相为甲醇-水(0.05mol·L-1磷酸缓冲盐,用磷酸调节pH=7.0)(75∶25),流速为1.0mL·min-1;检测波长220nm;柱温为30℃,进样量为20μL。结果:在该色谱条件下,氟曲马唑的浓度在10.47～670μg.mL-1范围内呈良好的线性关系,r=0.9995,平均回收率为99.3%(n=9),最低检测限为0.1μg.mL-1。结论:所建立的方法简便,专属性、重复性好,可用于氟曲马唑及有关物质的测定。

Objective：To establish an HPLC method for the assay of flutrimazole and its related substances.Methods：The separation and analysis was performed on a C18 column（250 mm×4.6 mm,5 μm）,the mobile phase consisted of methanol-phosphate buffer（75∶25）,the flow rate was 1.0 mL·min-1,the detection wavelength was set at 220 nm,the column temperature was 30 ℃,loaded volume was 20 μL.Results：A good linear relationship was obtained in the flutrimazole concentration of 10.47-670 μg·mL-1,r=0.9995.The average recovery was 99.3%（n=9）.The limit of detection was 0.1 μg·mL-1.Conclusion：The proposed method is simple,selective and reproducible,and can be used for the determination of flutrimazole and its related substance.