Investigation of Cyclam-Containing Mobile Phases for the Liquid Chromatographic Analysis of Tenidap

Tenidap is a new oxindole-based cytokine-modulating agent used for the treatment of arthritis. Initial analyses of tenidap for tenidap content and process-related impurities using reversed-phase liquid chromatography were unsatisfactory because of severe peak tailing and batch-to-batch column variability. These difficulties are overcome by addition of cyclam, a nitrogen crown ether analog, to the mobile phase. The improved chromatographic performance after addition of cyclam to the mobile phase may be attributable to changes in the configuration of tenidap.