顶空毛细管气相法测定盐酸左氧氟沙星中有机溶剂的残留量

Determination of Residual Organic Solvents in Levofloxacin Hydrochloride by Headspace Capillary Gas Chromatography

目的测定盐酸左氧氟沙星中有机溶剂的残留量。方法采用顶空进样程序升温法,FID检测器,色谱柱为HP-5毛细管柱(30m×0.32mm,0.25μm)。结果乙醇和N,N-二甲基甲酰胺(DMF)的线性相关系数分别为0.9996和0.9994,平均加样回收率为99.57%和98.89%,RSD为2.5%和1.1%(n=5)。结论所用方法简便、准确,灵敏度高,适用于盐酸左氧氟沙星中有机溶剂残留量的测定。

Objective To ＇develop the headspace capillary gas chromatography method for the determination of residual organic solvents in levofloxacin hydrochloride. Methods The samples were injected by headspace sampler with program heating and FID detector. The determination was performed on HP-5 GC column（30 m ×0. 32 mm, 0. 25 μm）. Results The regression coefficients of ethanol, DMF were 0. 999 6 and 0. 999 4 respectively. The average recovery rates were 99.57% and 98.89% with RSD were 2. 5% and 1.1% respectively. Conclusion The method is simple, accurate and sensitive with good reproducibility. It can be used for the determination of the residual organic solvents in levofloxacin hydrochloride.