复方酮康唑凝胶剂质量标准的研究  

Preparation and Quality Control of Compound Ketoconazole Gel

作　　者：黄文涛[1] 周进[1] 代能捷 杨盼鑫[1] 

机构地区：[1]武汉市中西医结合医院,湖北武汉430022

出　　处：《今日药学》2015年第6期425-427,共3页Pharmacy Today

摘　　要：目的建立复方酮康唑凝胶剂的质量标准。方法建立含量测定的高效液相色谱法,考察制剂的性状、p H。结果利用高效液相色谱法同时测定复方酮康唑凝胶剂中酮康唑与硝酸咪康唑的含量,其中酮康唑在0.408-20.4μg范围内有良好的线性关系（r=0.999 9）,平均回收率为100.3%,RSD=0.38%（n=6）。硝酸咪康唑在0.4-20.0μg范围内有良好的线性关系（r=0.999 9）,平均回收率=99.9%,RSD=0.79%（n=6）。其他检查指标均符合凝胶制剂相关技术要求。结论本凝胶剂制备工艺简单,含量测定操作简便,质量可控。OBJECTIVE To establish a new method for quality standard of compound ketoconazole gel. METHODS The concentration of compound ketoconazole gel was determined by HPLC,and the appearance,p H value were examined respectively.RESULTS HPLC method was established for simultaneous determination of ketoconazole, miconazole nitrate in compound ketoconazole gel. There were good linear correlations in the range of 0. 408- 20. 4 μg of ketoconazole（ r = 0. 999 9）,0. 4- 20. 0 μg of miconazole nitrate（ r = 0. 999 9）. The average recoveries of ketoconazole,miconazole nitrate were 100. 3%,RSD = 0. 38%（ n = 6）,99. 9% RSD = 0. 79%（ n = 6）. The indexes were in accordance with the standard of gels. CONCLUSION The preparing technology is simple and the established determination methods are reliable.

关 键 词：酮康唑 硝酸咪康唑 凝胶剂 HPLC 质量标准 

分 类 号：R927[医药卫生—药学]