摘要
目的建立GC法测定滴眼液瓶中环氧乙烷残留量的方法。方法采用顶空GC法,石英毛细管柱DB-WAX(30m×0.53mm×1μm);载气:氮气,恒压,流速:3.0ml·min^(-1),FID检测器,温度:250℃。结果环氧乙烷在0.2168~3.252μg·ml^(-1)呈良好的线性关系(r=0.9999),回收率为93.87%~98.16%,对照溶液和供试品溶液在室温条件下24h内稳定。结论用GC法测定环氧乙烷的残留量,方法准确可靠,可用于滴眼液瓶灭菌后环氧乙烷残留的检验。
Objective To establish a method for determination of ethylene oxide（EO） in the bottle of eye drops by Gas chromatography（GC）.Methods EO was determined by GC with DB-WAX capillary col umn（30 m×0.53 min×1μm） and an FID detector,with nitrogen as the carrier gas（3.0 ml·min ^-1）.The detection temperature was 250℃.Results Good linearity was obtained when the quality concentration of EO ranged from 0.2168 to 3.252μg·ml^-1 ,with a correlation coefficient 0.9999.The recovery was 93.87%-98. 16%.The standard solvent and the sample solvent could be stored for at least 24 h at room temperature. Conclusion This method is simple, sensitive and precise, which can be used for the determination of EO in the bottle of eye drops.
出处
《解放军药学学报》
CAS
CSCD
2017年第1期48-49,60,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
环氧乙烷
滴眼液瓶
GC
ethylene oxide
bottle of eye drops
GC
