摘要
建立复方丙酸氯倍他索涂膜剂的质量控制方法。方法:采用高效液相色谱法测定复方丙酸氯倍他索涂膜剂中丙酸氯倍他索的含量,紫外分光光度法测定水杨酸的含量。结果:水杨酸质量浓度在8～28μg/ml范围内与吸光度呈良好的线性关系(r=0.9998),低、中、高平均回收率分别为101.10%、99.35%、99.96%,RSD分别为0.26%、0.62%、0.56%(n=9);丙酸氯倍他索质量浓度在20.16～100.79μg/ml范围内与峰面积积分值呈良好线性关系(r=0.9999),低、中、高平均回收率分别为99.14%、100.20%、101.10%,RSD分别为0.62%、0.59%、0.79%(n=9)。结论:本法简单、快速、准确,可用于复方丙酸氯倍他索涂膜剂的质量控制。
OBJECTIVE： To establish the method for the quality control of Compound clobetasol propionate film. METHODS： HPLC method was adopted to determine the content of clobetasol propionate in Compound clobetasol propionate film, and UV spec- trophotometry was used to determine the content of salicylic acid. RESULTS： The linear range of salicylic acid was 8-28 ~tg/ml （r= 0.999 8） with an average recoveries of 101.10%, 99.35% and 99.96% at low, medium and high concentrations, RSD of 0.26%, 0.62%, 0.56% （n=9） ; that of clobetasol propionate was 20.16-100.79μg/ml （r=0.999 9） with an average recoveries of 99.14%, 100.20% and 101.10% at low, medium and high concentrations, with RSD of 0.62%, 0.59%, 0.79% （n=9）. CONCLUSIONS： The method is simple, rapid and accurate, which can be used for quality control of Compound propionate clobetasol film.
出处
《中国药房》
CAS
CSCD
2013年第5期435-437,共3页
China Pharmacy
