Purity method development for Ubrogepant and characterization of its degradation products

What is it about?

Creating a way to tell if a substance is stable or not by studying how it breaks down under stress and figuring out what products are left over after the breakdown using flash chromatography, NMR, IR, and LC-MS

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Why is it important?

This investigation is critical since Ubrogepant is a new chemical entity category, and there are currently no pharmacopeial monographs available. A comprehensive review of the literature reveals that only one HPLC method for the quantification of Ubrogepant in tablet formulation is accessible and there is no information degradation behavior of Ubrogepant. The investigation continues to separate and characterize the two major degradation products that are formed during acid and alkali hydrolysis. This is being done using spectroscopic techniques such as LC-MS, NMR (1H and 13C), and IR. The disclosed approach has the capability of identifying the degradation products of Ubrogepant at a concentration of 0.06 µg/mL.