盐酸加替沙星的有关物质研究  

Study on Related Substances of Gatifloxacin Hydrochloride

作　　者：俞利琴[1] 潘一斌[1] 

机构地区：[1]浙江医药股份有限公司新昌制药厂,浙江新昌312500

出　　处：《中国药业》2009年第22期30-31,共2页China Pharmaceuticals

摘　　要：目的建立盐酸加替沙星有关物质的定性及分离检测方法。方法采用高效液相色谱法,色谱柱为DiscoveryC18柱(250mm×4.6mm,5μm),流动相为三乙胺磷酸溶液(1→100稀三乙胺溶液,用磷酸调pH至4.5)-乙腈(87:13),检测波长为325nm,柱温为40℃。结果确证了盐酸加替沙星中有关物质结构,盐酸加替沙星的检测限为0.5ng。结论方法专属快速,可作为盐酸加替沙星有关物质的检测方法。Objective To establish a HPLC method for the identification and determination of the related substances in gatifloxacin hydrochloride. Methods The Discovery C18 column（250 mm×4.6mm,5μm） was used with the mobile phase of triethylamine-phosphoric acid solution （1--→100 diluted triethylamine solution, adjusted to pH 4.5 by phosphoric acid）- acetonitrile（87 ： 13）, the detective wavelength of 325 nm and the column temperature of 40 ℃. Results The structures of the related substance in gatifloxacin hydrochloride was verified, and its detection limit was 0. 5 ng. Conclusion This HPLC method is reliable and accurate, which can be used for the quality control of gatifloxacin hydrochloride.

关 键 词：盐酸加替沙星 有关物质 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学] R978.69