摘要
目的:建立甲磺酸左氧氟沙星中有机溶剂残留量的测定方法。方法:采用毛细管气相色谱法,色谱柱为HP-5毛细管柱(30m×0.32mm×0.25μm),柱温均为50℃,FID检测器,以N,N-二甲基甲酰胺为溶剂,载气为N2,进样口温度200℃,检测器温度300℃,分流比80:1,进样量1μL。结果:2种有机溶剂分离完全,且线性关系良好,线性范围分别为乙醇125.2～2003.2mg/L,正丁醇125.2～2002.4mg/L,乙醇和正丁醇的线性相关系数分别为0.9998和0.9996,平均回收率分别为99.54%、101.11%,最低检测限分别为7.1ng、11ng。结论:该方法灵敏、准确、可靠,适用于甲磺酸左氧氟沙星中有机溶剂残留量的检测。
Aim：To establish a method for determination of residual solvents in levofloxacin mesylate.Methods：Residual solvents in levofloxacin mesylate were determined by capillary gas chromatography using a HP-5 capillary column（30 m ×0.32 mm ×0.25 μm） with oven temperature at 50 ℃,a detector of FID,and N,N-dimethyllformamide as solvent,with input temperature at 200 ℃,nitrogen as the carrier gas,detector temperature 300 ℃,split ratio 80：1,and injection volume 1 μL.Results：The linear ranges of ethanol and n-butyl alcohol were 125.2 ～ 2 003.2 mg/L and 125.2 ～ 2 002.4 mg/L,respectively.And the linear correlation coefficient of ethanol and n-butyl alcohol was 0.999 8 and 0.999 6,respectively.RSD of precision and accuracy was less than 1.09% with average recoveries of 99.54% and 101.11%,respectively.The detection limits of ethanol and n-butyl alcohol were 7.1 ng and 11 ng,respectively.Conclusion：A sensitive,accurate,and applicable method for determination of residual organic solvents in levofloxacin mesylate has been established.
出处
《郑州大学学报（医学版）》
CAS
北大核心
2012年第2期254-256,共3页
Journal of Zhengzhou University(Medical Sciences)
