HPLC法测定糠酸莫米松乳膏含量

Determination of mometasone furoate by HPLC

目的对糠酸莫米松乳膏的含量进行方法学验证。方法采用HPLC法测定糠酸莫米松乳膏有关物质及含量。色谱条件:Amethyst C8(5μm,150 mm×4.6 mm),流动相:甲醇-水(72∶28),定量环:10μL,运行时间:2倍主峰保留时间UV检测器(检测波长254 nm);流速:1.0 mL·min-1。结果糠酸莫米松乳膏内标峰与主峰分离状况良好。在HPLC色谱中检测出糠酸莫米松含量在0.014 2~0.056 8 g·L-1的浓度范围内相关性良好,F=17.603×C-0.0026(R=0.999 98,n=7)。重复性、回收率、精密度良好,RSD均小于2%,该色谱系统稳定,溶液在24 h内稳定性良好。结论所建立的方法快速正确,重现性好,专属性强。

Objective To verify the method of content of Mometasone Furoate. Methods Determinating the content Mometasone Furoate by HPLC method. chromatographic conditions: C8packing( 5 μm,150 mm × 4. 6 mm; Amethyst),mobile phase: acetonitrile-water( 72∶28),the UV detector( detection wavelength 254 nm); flow rate:1.0 mL·min- 1; quantitative ring:10 μL; operating time:2 times the peak retention time. Results The impurity peak and peak separation in interior label of Mometasone Furoate well. The Mometasone Furoate in 0. 0142 g·L- 1and the linear range between 0. 056 8 g·L- 1good detection in HPLCchromatographic,the regression equation is F = 17. 603 × C- 0. 0026( R = 0. 999 98,n = 7). Repeatability,recovery rate,intermediate precision,good,RSD were less than2%,the chromatographic system stability,the solution was stable in 24 hours. Conclusion This method was fast and accurate with good reproducibility,specificity.