Drug Matrix Effect on the Determination of Residual Solvents in Bulk Pharmaceuticals by Wide-Bore Capillary Gas Chromatography

Abstract

A wide-bore capillary gas chromatographic method has been developed to study the drug matrix effect on the determination of residual solvents in bulk pharmaceuticals. A selective method is achieved on a Restek wide-bore (0.53-mm i.d. × 30 m) open-tubular fused-silica column coated with a 5-μm film of 95% dimethyl—5% diphenyl polysiloxane protected by a phenyl—methyl siloxane deactivated, uncoated fused-silica guard column. Utilizing this method, several common process solvents in weakly acidic, weakly basic, and neutral drug matrices are evaluated by recovery and linearity studies to show whether or not a drug matrix effect exists in their determination.