反相高效液相色谱法检测曲咪新乳膏中醋酸曲安奈德与硝酸咪康唑含量

Simultaneous Determination of Contents of Triamcinolone Acetonide Acetate and Miconazole Nitrate in Triamcinolone Acetonide Acetate and Miconazole Nitrate and Neomycin Sulfate Cream by RP-HPLC

目的建立同时测定曲咪新乳膏中醋酸曲安奈德和硝酸咪康唑含量的反相高效液相色谱法(RP-HPLC)方法。方法色谱柱为Diamonsil C18(200mm×4.6mm,5μm),以0.5%醋酸铵溶液-乙腈-甲醇(15:42.5:42.5)为流动相,流速为1.0mL·min-1,检测波长为272nm,以邻苯二甲酸二丁酯为内标的分析方法。结果醋酸曲安奈德浓度在64.08～149.52μg·mL-1呈良好的线性关系(r=0.9999),制剂平均回收率为99.6%,RSD=0.43%(n=6);硝酸咪康唑浓度在600.6～1401.4μg·mL-1呈良好的线性关系(r=0.9999),制剂平均回收率为100.0%,RSD=0.49%(n=6)。结论该方法简单,快速,准确,为该制剂的质量控制提供了依据。

Objective To establish an RP-HPLC method for the simultaneous determination of contents of triamcinolone acetonide acetate and miconazole nitrate in triamcinolone acetonide acetate and miconazole nitrate and neomycin sulfate cream. Methods RP-HPLC was conducted using a Diamonsil C18 column （200 mm × 4.6 mm ,5 μm） , with a mobile phase of 0.5% ammonium acetate solution--acetonitrile--methanol （ 15 ： 42.5 ： 42.5 ） and flow rate of 1.0 mL · min^-1. Samples was detected at 272 nm, with dibutyl phthalate as internal standard. Results The linear range was 64.08 - 149.52 μg·mL^-1 （ r = 0. 999 9） and the average recovery rate was 99.6%, RSD = 0.43 % （ n = 6 ） for triamcinolone acetonide acetate. The linear range was 600.6 - 1 401.4 μg·mL^-1 （ r = 0. 999 9 ）, the average recovery rate was 100.0% , RSD = 0.49% （ n = 6 ） for miconazole nitrate. Conclusion The method was accurate, simple and effective. It might effectively be applied to control the quality of agent.