Sensitive determination of impurities in achiral pharmaceuticals by supercritical fluid chromatography using the Agilent 1260 Infinity Analytical SFC System

Supercritical Fluid Chromatography is an alternative and complementary method to HPLC for the determination of impurities in pharmaceutical products. This study evaluated the performance of the Agilent 1260 Infinity Analytical SFC system for the analysis of thiourea in two model compounds. The study included both isocratic and modifier gradient modes. The resulting data showed excellent linearity and repeatability. Retention time repeatability was better than 0.1%. Limits of detection for the impurity determination were below 0.01% w/w relative to the main compound, and the RSDs of peak area were below 1% at the 0.5% concentration level and below 5% at the 0.05% concentration level in all cases. These values are well within acceptable method validation ranges. Authors Melissa N. Dunkle, Alberto dos Santos Pereira, Frank David, Pat Sandra Research Institute for Chromatography Kennedypark 26, 8500 Kortrijk Belgium Application Note