Determination of Residual Organic Solvents in Dimemorfan Phosphate by GC / 中国药师

ABSTRACT

Objective:To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy (GC). Methods:The capillary gas chromatography was used with a PEG-20M column, programmed temperature, water as the solvent and FID as the detector. Results:The three organic solvents were separated and showed good linear relationship (r>0. 999 0). The detection limit of chloroform, ethyl acetate and DMF was 0. 63,0. 60 and 8. 92μg·ml-1 , respectively. The residues of the organ-ic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive, accurate and reliable, and can be used in the quality control of dimemorfan phosphate.