盐酸左氧氟沙星眼用即型凝胶的研制

Studies and Preparation of the Levofloxacin Hydrochloride in Situ Forming Eye Gel

目的:探讨盐酸左氧氟沙星眼用即型凝胶的制备及质量控制方法。方法:以卡波姆为基质制备凝胶,采用高效液相法测定含量。结果:左氧氟沙星浓度在9.86～98.62μg·ml^(-1)范围内线性关系良好,平均回收率为99.28%,RSD为1.00%。结论:本方法处方设计合理,制备方法简便,含量测定方法适用于本品质量控制。

Objective： To develop a preparation and quality control method for the levofloxacin hydrochloride in situ forming eye gel. Method： The levofloxacin hydrochloride in Situ Forming Eye Gel was prepared with carbopol as base, it was dertimined by HPLC. Result： The linear range of Levofloxacin was 9.86 -98.62 μg·ml^-1 The recovery was 99.28% , RSD was 1.00%. Conclusion： The formulation of this preparation was reliable and preparation method is simple. The method of content determination is suitable for quality control of the preparation.