HIGH-PERFORMANCE, PURITY-INDICATING LIQUID-CHROMATOGRAPHIC METHOD FORTHE OXYTOCIN ANTAGONIST, L-368,899

This work describes the high-performance liquid chromatographic (HPLC) methodology used for the analysis of an oxytocin antagonist (L-368,89 9). The chromatography separates the drug from its major impurity (exo -isomer), four synthetic intermediates and two key raw materials. The method development process, which was required to achieve baseline sep aration of the eight components, reveals the subtleties and complexiti es involved in chromatographic method development. The optimized LC me thod was validated and found to be rugged and reproducible for the imp urity profiling of this oxytocin antagonist drug.