高效液相色谱法测定氟曲马唑含量和有关物质

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(250 mm×4.6 mm,5 μm)色谱柱,流动相为甲醇-水(0.05 mol·L^-1磷酸缓冲盐,用磷酸调节pH=7.0)(75∶ 25),流速为1.0 mL·min^-1;检测波长220 nm;柱温为30 ℃,进样量为20 μL。 结果: 在该色谱条件下,氟曲马唑的浓度在10.47~670 μg·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0.1 μg·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.