Determination of Residual Organic Solvents in Palonosetron by Capillary Gas Chromatography

[Objective]To determine the contents of the residual methanol,toluene,ethyl acetate,acetone,ethanol,tetrahydrofuran,isopropylalcohol,and n-hexane in palonosetron.[Methods]A simple capillary gas chromatography method was established with FID detector.The capillary column was HP-5 with programed temperature rsing.The residues were calculated by an external standard method.[Results]The linearity of all the eight residual solvents was fairly good.The average recoveries were 96.35%-103.67% with RSD of 1.37%-3.04%.The limit of detection was 0.27-0.38 ng.The contents of the eight residual organic solvents in three batches of samples all reached the standard requirements.[Conclusion]The method was proved to be accurate,sensitive and reliable.It is suitable for the test analysis of the eight kinds of solvents.