Identification and characterization of degradation products of Remdesivir using liquid chromatography/mass spectrometry†

Remdesivir (RDV), a nucleoside analogue prodrug, is used to treat viral diseases including COVID-19. The drug (RDV) was stressed under acidic, basic and neutral hydrolysis, oxidation, photolysis, and thermal conditions according to the International Council for Harmonisation (ICH) prescribed guidelines Q1A (R2). A total of nine degradation products were formed under acidic (DP1-DP5), basic (DP5-DP8) and neutral (DP5) hydrolysis, and oxidation (DP9) stress conditions, whereas the drug was found to be stable under thermal and photolytic stress conditions. The structures of the degradation products were elucidated by using a simple and rapid ultra high-performance liquid chromatography coupled to electrospray interface with quadrupole time-of-flight tandem mass spectrometer (UPLC/ESI-Q-TOF-MS/MS) method.

Automated summary

Remdesivir (RDV), a nucleoside analogue prodrug used to treat viral diseases, was subjected to stress testing under various conditions according to ICH guidelines. Degradation products were formed under acidic, basic and neutral hydrolysis, and oxidation stress conditions, while the drug remained stable under thermal and photolytic stress conditions. The structures of degradation products were identified using a UPLC/ESI-Q-TOF-MS/MS method.