RP-HPLC法同时测定硝酸咪康唑氯倍他索乳膏中两种有效成分的含量

Simultaneous determination of two main components in compound miconazole nitrate cream by RP-HPLC

目的建立高效液相色谱法同时测定硝酸咪康唑氯倍他索乳膏中硝酸咪康唑和丙酸氯倍他索的含量.方法色谱柱为luna C18柱(4.6mm×250mm,5μm),流动相为甲醇:乙腈: 0.5%乙酸铵溶液(41:41 : 18),流速1.0ml/min,检测波长240nm.结果硝酸咪康唑和丙酸氯倍他索分别在0.08～3.20和0.021～0.084mg/ml浓度范围内与峰面积呈良好的线性关系(r=1.0000和r=0.9999),高、中、低3种浓度的平均回收率范围为100.7%～101.5%(RSD≤0.3%)和99.8%～100.7%(RSD≤0.5%).结论本方法简单、快速、灵敏度高和重现性好,能够有效地控制药品质量.

Objective A quantitative method was established to determine miconazole nitrate and clobetasol propionate simultaneously in compound miconazle nitrate cream by RP-HPLC. Method Luna C18 column （4.6mm × 250mm, 5μm） was used with methanol：acetonitrile ： 0. 5% ammonium acetate solution （41：41： 18） as mobile phase. The flow rate was 1. 0 ml/min. Detection wavelength was 240nm. Results The calibration curves showed a good linearity in the range of 0.08～3.2mg/ml for miconazole nitrate （r= 1.0000） and 0.021～0.084mg/ml for clobetasolpropionate （r=0.9999）. The average recoveries were 100.7%～101.5%（RSD≤0.3%） and 99.8～10.7% （RSD≤0.5%） for three different levels of the prepared solutions, respectively. Conclusion The method is simple, rapid, sensitive and reproducible. It can be used to control the quality of this preparation.