盐酸加替沙星滴眼液的制备及质量控制  

Preparation and Quality Control of Gatifloxadn Hydrochloride Eye-drops

作　　者：林建设[1] 白乐溪[1] 

机构地区：[1]中国人民解放军第一七四医院,厦门361003

出　　处：《中国药师》2006年第5期444-445,共2页China Pharmacist

摘　　要：目的:建立盐酸加替沙星滴眼液的制备方法及质量控制方法。方法:取盐酸加替沙星加氯化钠制成0．3％盐酸加替沙星滴眼液,以磷酸盐缓冲液-乙腈(83:17)为流动相,检测波长为286 nm,反相高效液相色谱法测定盐酸加替沙星的含量。结果:该方法能很好分离被测组分与其它杂质,线性范围为50-350μg·ml-1(r=0．999 3),平均回收率为99．4％,RSD 1．1％。结论:制备工艺简单,质量可控。Objective： To establish a methods of the preparation and quality control of Gatifloxacin Hydroehloride eye-drops. Method： Gatifloxacin Hydrechloride eye-drops was prepared. The coneertration was 0.3%. A C18 column was used with the mobile phase of PBS solufion-acetonitrile （83： 17） at the detection wavelength of 286 nm. Result： The linear range of Gatifloxacin Hydrochloride was 50-350μg·ml^-1, r = 0. 999 3. The average recovery was 99.4% , RSD = 1.1%. Conclusion： The preparation process of Gatifloxacin Hydrochloride eye-drops is simple and the method of quality control by HPLC is reliable. K

关 键 词：加替沙星滴眼液 制备 质量控制 高效液相色谱法 

分 类 号：R944.12[医药卫生—药剂学]