Development and validation of a high-precision capillary electrophoresis method for main component assay of ragaglitazar

The ability of a developed capillary electrophoresis (CE) method for fast, efficient and reliable main component assay of ragaglitazar [NNC 61-0029/DRF(-)2725] has been demonstrated through documentation of the analytical performance and the results of a successful validation. The fast analysis time of around 1.2 min ensures a high analytical capacity, and the validation results show that the CE method is robust and gives reliable and precise results. The results from the validation of the CE method meet the acceptance criteria that are normally set for other main component assays such as high-performance liquid chromatography assays.