Determination of 9 residual solvents in the new drug Ⅰb by capillary gas chromatography
JI Yi-bing
ZHANG Yu
XU Jin-yi
WU Xiao-ming
Abstract：Objective:To establish a method for determining residual solvents in Ⅰb by capillary gas chro-matography. Methods:The capillary column was DB-624 capillary column (30.0 m×530 μm, 3.00 μm), and FID was used as the detector. The residual solvents, methanol, ethanol, ether, dichloromethane, n-hexane, ethyl acetate, toluene, and N,N-dimethylformamide were analyzed after direct injection, and N-butanol was used as the internal standard. Another residual solvent, chloroform, was determined with electron capture detector (ECD) ,and calculated by external standard method. Results:Within the range of experimental concentrations, a good linearity was obtained(r > 0.999 4). The average recovery was in 97.1%～103.3%. Conclusion: This method is sensitive, accurate and repeatable. It can be used to determine the residual solvents in Ⅰb.
Keywords：capillary gas chromatographyresidual solventdirect injectionⅠb
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2163-2166 )