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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 HPLC determination of flumazole and its related substances. Methods: The HPLC column of Dalian ELITE C18 (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-water (0.05 mol·L-1 phosphate buffer, adjusted to pH 7.0 with phosphoric acid) 1.0mL · min-1; detection wavelength was 220nm; column temperature was 30 ℃, injection volume was 20μL. Results: Under the chromatographic conditions, the concentration of flumexacarb was linear in the range of 10.47-670μg.mL-1, r = 0.9995 with the average recovery of 99.3% (n = 9). The minimum detection limit was 0.1 μg.mL-1. Conclusion: The established method is simple, specific, reproducible, and can be used for the determination of flumazole and related substances.