Method Development And Validation Of Odevixibat By HPLC And Characterization Of Its Novel Stress Degradation Products By Using HPLC-MS/MS

Abstract

Background: For evaluating Odevixibat and its degradation products that were identified by LC-MS/MS, a sensitive and simple method was developed.

Results: This method uses a 250 x 4.6 mm, 5 µm long Inertsil ODS C18 column for chromatographic separation. With a flow rate of 1 mL/min and ambient temperature, a mobile phase containing 0.1% formic acid (FA) and acetonitrile in a ratio of 60:40 was utilized. At 220 nm, UV observations were made. The linearity, recoveries, and quantification limitations were found to be within the allowable range.

Conclusions:  Newly produced Odevixibat breakdown products and stress studies were confirmed as chemical structures using LC-MS in accordance with ICH Q2 (R) standards.