复方糠酸莫米松乳膏的研制及含量测定

Preparation and Content Determination of Compound Mometasone Furoate Cream

目的制备复方糠酸莫米松乳膏,建立对其主要成份糠酸莫米松、硝酸益康唑和尿囊素的含量测定方法。方法通过选择不同的乳化剂,进行处方筛选。采用高效液相色谱法测定含量。结果通过选择不同的乳化荆,确定了最佳处方。建立了测定复方糠酸莫米松乳膏含量的方法,结果糠酸莫米松三个浓度的平均回收率分别为99.30%,98.98%和100.2%;RSD(n=3)分别为0.11%,0.32%和0.25%;硝酸益康唑的平均回收率分别为99.12%,99.47%和100.5%;RSD(n=3)分别为0.15%,0.38%,0.27%;尿囊素的平均回收率分别为99.27%,99.98%和101.1%;RSD(n=3)分别为0.25%,0.39%,0.37%,线性关系良好。结论处方设计合理。测定方法灵敏度高,专属性好,适用于复方糠酸莫米松乳膏的含量测定。

OBJECTIVE Preparation of compound mometasone furoate cream and establish a method for determination of the content of the main ingredient mometasone furoate,econazole nitrate miconazole and allantoin. METHODS Through the choice of different emulsifier to screen the optimal prescription. Determination of content by high performance liquid chromatography. RESULTS The best formula was determined by selecting different emulsifying agent. Method was established for the determination of compound mometasone furoate cream content,average recovery of the three concentrations of mometasone furoate were 99. 30%,98. 98% and 100. 2%; RSD（ n = 3）were 0. 11%,0. 32% and 0. 25%; average recovery of econazole nitrate were 99. 12%,99. 47% and 100. 5%; RSD（ n = 3） were 0. 15%,0. 38%,0. 27%; the average recovery rate of allantoin was 99. 27%,99. 98% and 101. 1%;RSD（ n = 3） were 0. 25%,0. 39% and 0. 37%,linear relationship was good. CONCLUSION Reasonable prescription was designed. The determination method of high sensitivity,good specificity,and suitable for the determination of compound Mometasone Furoate Cream.