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目的:建立高效液相色谱法测定氟曲马唑乳膏的含量及其有关物质,为氟曲马唑乳膏制定质量控制标准。方法:采用Diamonsil C_(18)谱柱(250 mm x4.6 mm,5μm),乙腈-0.05 mol·L~(-1)磷酸盐缓冲溶液(用20%磷酸调节pH=7.2)(70:30)为流动相,柱温25℃,检测波长为220 nm,流速为1.0 ml.min~(-1)。结果:氟曲马唑在20～200μg·ml~(-1)范围内线性关系良好(r=0.999 9),平均回收率99.6%,3批样品测定结果平均标示百分含量为98.52%,97.71%,99.08%。结论:该方法简便、快速、准确、灵敏度高、重复性好,可用于氟曲马唑乳膏的含量及有关物质的测定。
Objective: To establish a HPLC method for the determination of flumazole cream and its related substances, and establish the quality control standard for flumestine cream. METHODS: Diamonsil C 18 column (250 mm × 4.6 mm, 5 μm), acetonitrile-0.05 mol·L -1 phosphate buffer (adjusted to pH 7.2 with 20% phosphoric acid) (70:30 ) As mobile phase, the column temperature was 25 ℃, the detection wavelength was 220 nm and the flow rate was 1.0 ml.min ~ (-1). Results: The calibration curve was linear in the range of 20-200 μg · ml -1 (r = 0.999 9), with an average recovery of 99.6%. The mean percentage of labeled samples was 98.52% and 97.71 %, 99.08%. Conclusion: The method is simple, rapid, accurate, sensitive and reproducible. It can be used to determine the content of flumazole cream and its related substances.