Determination of Residual Organic Solvents in Tegaserod Maleate by Capillary Gas Chromatography

Purpose To determine the contents of residual methanol, ethanol,acetone, aether, petroleum ether, ethylacetate, iodomethane, acetic acid, n-amylamine,diethyl oxalate and DMF in Tegaserod Maleate. Methods A simple capillary gas chromatography method was established with FID detector. The capillary column was HP-5, using temperature program; The residues were calculated by the external standard method. Results The linearities were fairly good. The average recoveries were 86. 87 % - 98. 45 % with RSD of 1. 34% - 6. 56%. The limit of detection was 0. 29 - 1. 06 ng. The contents of eleven residual organic solvents in four batches of samples were complied with the specification requirements. Conclusions After validation, the method was proved to be accurate,sensitive and reliable. It is suitable to be adopted in the analysis of the tested solvents.