复方司帕沙星滴耳液的制备及质量控制

目的:制备复方司帕沙星滴耳液并建立其质量控制方法。方法:以甘油和乙醇为溶剂制备滴耳液,采用紫外分光光度法于360nm波长处测定益康唑含量,于297nm波长处测定司帕沙星含量,并考察其稳定性。结果:益康唑和司帕沙星检测浓度线性范围分别为2～400、0.4～80μg/ml,平均回收率分别为100.96%(RSD=0.99%)、100.38%(RSD=0.44%);成品有效期可达2y以上。结论:该制剂制备工艺简单、稳定性好,质量控制方法简易、快速、可行。

Preparation and Quality Control of Compound Sparfloxacin Auristillae

OBJECTIVE:To prepare compound sparfloxacin auristillae and to establish its quality control method.METHODS:The auristillae was prepared with glycerin and alcohol as solvents;the contents of econazole and sparfloxacin were determined by UV spectrophotometry with their respective detection wavelengths at360nm and297nm respectively,and the stability of which were determined as well.RESULTS:The linear concentration ranges of econazole and sparfloxacin were2～400μg/ml and0.4～80μg/ml respectively;the average recovery of econazole and sparfloxacin were100.96%(RSD=0.99%)and100.38%(RSD=0.44%)respectively.The expiry date(shelf life)of the finished products was above2years.CONˉCLUSION:The preparation is simple in preparation,good in stability;and the quality control method is simple and easy,rapid,accurate and feasible.