Objective To establish a GC method for the determination of ethylene glycol,diethylene glycol and trithylene glycol in suspending solution used for microspheres for injection.Methods The gas chromatography analyses were performed on a HP-INNOWAX capillary column(30 m×0.32 mm,0.5 μm).Both of the inlet temperature and the FID detector temperature were controlled at 250 ℃.Programmed temperature was adopted.The flow rate of earried gas(N2)was 1.0 ml/min.The split ratio was 1∶1.Results The 3 components were completely separated.The limits of quantitative were 1.174,1.166,1.079 μg/ml,respectively.Glycol,diethylene glycol and trithylene glycol showed a good linear relationship within the range of 1.174～234.80、1.166～233.28 and 1.079～215.76 μg/ml(r＞0.999).The average recovery was 96.2％(RSD=3.1％),96.3％(RSD=3.1％),101.6％(RSD=5.2％)(n=6),respectively.No residue of these solvents was detected in 4 batches of suspending solution.Conclusion This method can be applied to determine the ethylene glycol,diethylene glycol and trithylene glycol in suspending solution.
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维普
