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目的:建立高效液相色谱法同时测定复方曲安奈德咪康唑乳膏中硝酸咪康唑和氯霉素含量的方法。方法:以十八烷基硅烷键合硅胶为填充剂,开始以甲醇-0.5%醋酸铵水溶液-乙腈(17:66:17)为流动相,洗脱至氯霉素峰出峰完全,变为甲醇-0.5%醋酸铵水溶液-乙腈(45:10:45),洗脱至硝酸咪康唑峰出峰完全;检测波长227nm;流速1.0ml·min~(-1),进样量10μl,柱温为室温。结果:氯霉素与硝酸咪康唑浓度在0.16～0.56 mg·ml~(-1)范围内线性关系良好(r=1.000 0,r=0.998 7),平均加样回收率分别为100.10%(RSD=1.07%),100.61%(RSD=1.73%)。结论:该方法简便、可行、重现性好,可用于复方曲安奈德咪康唑乳膏质量控制。
Objective: To establish a method for simultaneous determination of miconazole nitrate and chloramphenicol in compound triamcinolone cream by high performance liquid chromatography. Methods: Octadecylsilane bonded silica gel was used as the filler, starting with methanol - 0.5% ammonium acetate aqueous solution - acetonitrile (17:66:17) as mobile phase, Methanol-0.5% ammonium acetate aqueous solution-acetonitrile (45:10:45), eluting to the peak of miconazole nitrate peak completely; the detection wavelength was 227nm; the flow rate was 1.0ml · min -1, The temperature is room temperature. Results: The linearity was found between chloramphenicol and miconazole nitrate in the range of 0.16-0.56 mg · ml -1 (r = 1.000 0, r = 0.998 7). The average recoveries of chloramphenicol and miconazole were 100.10% RSD = 1.07%), 100.61% (RSD = 1.73%). Conclusion: The method is simple, feasible and reproducible. It can be used for the quality control of compound triamcinolone acetonide cream.