司帕沙星眼用凝胶质量控制方法研究

Study of Quality Control Method of Sparfloxacin Ophthalmic Gel

目的建立司帕沙星眼用凝胶的质量控制方法。方法观察以卡波姆-940为基质制备的司帕沙星眼用凝胶的外观性状,用pHS-25C型数字酸度计测定其pH,在297 nm波长处采用紫外分光光度法测定其中主药的含量。结果所得制剂为淡黄色胶体,凝胶质量符合2010年版《中国药典(二部)》中眼用凝胶的质量要求;司帕沙星质量浓度在2.04～14.28μg/mL范围内与吸光度线性关系良好,r=0.999 95(n=7),平均回收率为99.48%,RSD为0.73%(n=6)。结论司帕沙星眼用凝胶的质量控制方法可行,采用紫外分光光度法测定其主药含量准确、快速。

Objective To and to establish quality control method of sparfloxacin ophthalmic gel.Methods Carbomer-940 was used as matrix to prepare Sparfloxacin Ophthalmic Gel.The appearance of the gel was observed and the pH value of it was determined by pHS-25C digital acidometer.The content of sparfloxacin in the gel was determined by ultraviolet spectrophotometer at the wavelength of 297 nm.Results Sparfloxacin Ophthalmic Gel was faint yellow colloid and it accorded with relative quality requirement of Chinese Pharmacopoeia（2005）.A linear calibration curve for assay of sparfloxacin was obtained in the range of 2.04-14.28 μg/mL,r=0.999 95（n=7）and the average recoveries were 99.48%,RSD=0.738（n=6）.Conclusion The quality control method of Sparfloxacin Ophthalmic Gel is feasible,and it is accurate and fast that the content of sparfloxacin in the gel is determined by ultraviolet spectrophotometer.