Gas chromatographic method for solvent residues in drug raw materials.
A gas chromatographic (GC) method for screening drug raw materials, soluble in aqueous media, for volatile solvent residues has been developed. After dissolution, separate portions of the drug are each separately extracted with n-octane, toluene, and ether and injected into a chromatograph equipped with a porous polymer column and a flame ionization detector. The range of extractant polarities provides chromatograms which, taken together, are free of interfering peaks from 0 to approximately 20 min. Peaks due to solvent residues in the drug are identified by retention time with confirmation of identity by GC-MS.
D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012995:Solubility; D012997:Solvents / Q000032:analysis*
D004364:Pharmaceutical Preparations; D012997:Solvents