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