复方炉甘石洗剂含量测定的方法学验证

摘要

目的 建立测定复方炉甘石洗剂的质量控制方法,并进行方法学研究.方法 采用EDTA络合滴定法,测定制剂中锌化物的含量.结果 该方法测定锌化物的浓度,在0.020 02 g/ml～0.100 12 g/ml范围内呈良好的线性关系,平均回收率为100.04%,RSD为0.20%.结论 所制定的复方炉甘石洗剂的质量控制方法可行.%Objective To establish the quality control method for the determination of compound calamine lotion,and to make methodological study. Methods EDTA complexometric titration method was used to determine the concentration of zinc compound in the preparation. Results The concentration of zinc compound had a good linear relation within the range of 0. 02002 - 0. 10012 g/ml. The average recovery rate was 100. 04% , and RSD was 0. 2% . Conclusion This quality control method for the determination of compound calamine lotion is feasible.