复方氧氟沙星凝胶的制备及质量控制

Preparation and Quality Control of Compound Ofloxacin Gel

目的:制备复方氧氟沙星凝胶并建立其质量控制方法.方法:以氧氟沙星为主药配伍地塞米松磷酸钠,选择卡波姆-940作为基质,采用高效液相色谱法测定氧氟沙星、地塞米松的含量.结果:氧氟沙星、地塞米松磷酸钠检测浓度线性范围分别为20～300、5～50μg/ml,平均回收率分别为(99.8±0.5)%(RSD=0.84%)、(100.6±0.8)%(RSD=0.87%).结论:该制剂质量稳定,制备工艺简单,质控方法可靠.

OBJECTIVE： To prepare compound ofloxacin gel and to establish its quality control method. METHODS： Ofloxacin was used as principal agent to be mixed with dexamethasone sodium phosphate, carbomer 940 was taken as base material, the content of ofloxacin and dexamethasone were determined by HPLC method. RESULTS： The linear detection concentration ranges of ofloxacin and dexamethasone were 20～300μg/ml and 5～50μg/ml, respectively, the average recovery rates of which were （99.8±0.5）% （RSD=0.84%） and （100.6±0.8）% （RSD=0.87% ）, respectively. CONCLUSION： The preparation is stable in quality, the prepare technique is simple and the quality control is reliable.