Open AccessSTRUCTURE CHARACTERIZATION OF STRESS DEGRADATION PRODUCTS OF ELAGOLIX BY USING HRMS, NMR
Author(s) -
S. S. K. Chakravarthy Kotha,
K.V.K. Mohan P,
Raju Doddipalla,
Dasameswara Rao Kavitapu,
Chidananda Swamy Rumalla,
Himabindu Gandham,
Muralidharan kaliyaperumal
Publication year - 2022
Publication title -
rasayan journal of chemistry/rasayan journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.281
H-Index - 22
eISSN - 0976-0083
pISSN - 0974-1496
DOI - 10.31788/rjc.2022.1516527
Subject(s) - trifluoroacetic acid , chemistry , degradation (telecommunications) , acetonitrile , forced degradation , high performance liquid chromatography , chromatography , nuclear magnetic resonance spectroscopy , reversed phase chromatography , organic chemistry , computer science , telecommunications
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