摘要
目的:建立HPLC法测定甲磺酸培氟沙星及其注射剂有关物质。方法:C18色谱柱,流动相为乙腈-2.70g/十六烷基三甲基溴化铵与6.18g硼酸溶液的混合溶液(用1mol/L氢氧化钠溶液调pH值至8.30)-硫二甘醇(30∶70∶0.2),检测波长为273nm。结果:培氟沙星与同系物及相关杂质分离良好。结果:本方法结果准确、专属性强,更适用于甲磺酸培氟沙星有关物质的检测。
Objective： To establish a method for the related substance of pefloxacin meylate and Pefloxacin Mesylate for Injection by HPLC. Methods： The analysis was conducted by HPLC using a Cl8 colmnn. The mobile phase was aeetonitrile-mixture of 2.70 g/L eetyhrimethylammonium bromide with 6.18 g/L boric acid solution （adjusted to pH 8.30 with 1 mol/L sodium hydroxide）-2, 2-thiodiglycol （30∶70∶0.2）. The detection wavelength was set at 273 nm. Results： The resolution between the respective peaks of pefloxacin mesylate with the other peaks conformed to the requirements. Conclusion： The method is simple, accurate and specific, and reproducible for the related substance of pefloxacin mesylate and Pefloxacin Mesylate for Injection.
出处
《中国当代医药》
2010年第27期59-60,共2页
China Modern Medicine
