盐酸左氧氟沙星液状眼用凝胶的制备及质量控制

Preparation and Quality Control of the Levofloxacin Ophthalmic Gel

目的:建立盐酸左氧氟沙星液状眼用凝胶的制备及质量控制方法。方法:以卡波姆为增粘剂,制备盐酸左氧氟沙星液状眼用凝胶,以XTerra RP18色谱柱为分离柱,以0.1%磷酸:乙腈(87∶13)为流动相,采用HPLC法测定。结果:左氧氟沙星浓度在10.2～51.2μ·ml^(-1)范围内线性关系良好,r=0.999 9。左氧氟沙星的平均回收率为99.60%,RSD=0.61%。结论:此法操作简单、结果准确,可用于盐酸左氧氟沙星液状眼用凝胶的质量控制。

Objective： To preparation levofloxacin ophthalmic gel and to establish a quality standard of this preparation. Method： Levofloxacin ophthalmic gel was prepared with carbopol as thickener, a XTerra RP18 radial compression column was used, and mobile phase was 0.1% phosphoric acid-acetonitrile （ 87 ： 13 ）. Result： The linear range of levofloxacin was 10, 2 - 51.2 μg·ml-1 （ r = 0.999 9） and the average recovery was 99.60%, RSD = 0.61%. Conclusion： This method was simple and feasible for the quality con- trol of levofloxacin ophthalmic gel.