Analysis of solvent residues in pharmaceutical bulk drugs by wall-coated open tubular gas chromatography.
A simple general method for the determination of solvent residues in drugs is described. The procedure is based on wide-bore wall coated open tubular (WCOT) gas chromatographic analysis of bulk drug solutions. The use of wide-bore WCOT columns with chemically crosslinked methyl silicone stationary phases offers improvements in specificity and sensitivity over earlier packed-column methods. The factors that influence method accuracy are discussed, including a consideration of instrumental and matrix contributions to the linearity and bias of the method. Some problems with interferences peculiar to benzyl alcohol are reported.
Foust
D W
DW
Upjohn Company, Control Division, Kalamazoo, MI 49001.
Bergren
M S
MS
D002849:Chromatography, Gas / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012997:Solvents / Q000032:analysis*
D004364:Pharmaceutical Preparations; D012997:Solvents