加替沙星眼用凝胶剂的制备与质量控制

Preparation and quality control of gatifioxacin ophthalmic gel

目的:制备加替沙星滴眼用凝胶剂并建立其质量控制方法。方法:以卡波姆974P为凝胶基质,以NaCl为渗透压调节剂,尼泊金乙酯为抑菌剂,制备加替沙星眼用凝胶剂;采用高效液相色谱法测定加替沙星的含量,测定波长为325 nm。结果:制剂为无色澄明液体,质量符合2010年版《中国药典》中的相关规定;加替沙星浓度在15.00～180.00μg/mL范围内线性关系良好(r=0.999 9),平均回收率为99.71%(RSD=0.63%)。结论:该处方工艺简单、实用,质量控制方法可靠、易行。

Objective： To investigate the preparation of gatifloxacin ophthalmic gel and establish the methods for the quality control. Methods： Gatifloxacin ophthalmic gel was prepared by utilizing carbomer 974P as gel matrix, NaCI as osmoregulation agent and ethylparaben as bacteriostatic agent. The concentration of gatifloxacin in the gel formulation was determined by HPLC with the detection wavelength at 325 nm. Results： Preparation was a colorless transparent liquid and the quality satisfied the relevant formulations in the 2010 edition of ＂Chinese Pharmacopoeia＂. The concentration of gatifloxacin determined by HPLC was linear in the range of 15-180 μg/ mL（r=0.999 9）. Its average recovery rate was 99.71% （RSD=0.63%, n=9）. Conclusion： The formulation and preparation of gatifloxacin ophthalmic gel are simple and practical. The methods for its quality control are reliable and easy.