STRUCTURE CHARACTERIZATION OF STRESS DEGRADATION PRODUCTS OF ELAGOLIX BY USING HRMS, NMR

Abstract

Elagolix Sodium is a recently approved drug used to treat endometriosis in women. Elagolix sodium was exposed to forced degradation (acid, base, neutral, oxidative, thermal, and photolytic) as per International Council for Harmonisation guidelines. Present work describes the structure characterization of Elagolix sodium and its degradants. Three novel degradation products were observed when subjected to oxidative degradation and the drug was stable in other stress conditions. A gradient LC-MS method was developed to separate all the degradants and the Elagolix by using Acquity BEH C18 column with Trifluoroacetic acid and Acetonitrile as mobile phase. Preparative HPLC was used to separate the degradants, further confirmed structurally with HRMS and NMR spectroscopy. The degradation products are novel, not reported earlier.