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.
Upjohn Company, Control Division, Kalamazoo, MI 49001.
D W
DW
Foust
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MS
Bergren
D002849:Chromatography, Gas / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012997:Solvents / Q000032:analysis*
D004364:Pharmaceutical Preparations; D012997:Solvents