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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 establish the preparation and quality control method of levofloxacin liquid ophthalmic gel. METHODS: Liquid eye gel of levofloxacin hydrochloride was prepared with carbomer as thickener. The mobile phase consisted of 0.1% phosphoric acid: acetonitrile (87:13) with XTerra RP18 as the separation column and determined by HPLC method. Results: The levofloxacin concentration was good in the range of 10.2 ~ 51.2μ · ml ~ (-1), r = 0.999 9. The average recovery of levofloxacin was 99.60%, RSD = 0.61%. Conclusion: This method is simple, accurate and can be used for the quality control of levofloxacin hydrochloride liquid ophthalmic gel.