Determination of GS-441524 in The Polyethylene Glycol Preparation by HPLC Coupled with High Resolution Mass Spectrometry

Hua Wang

GS-441524, PEG-400, HPLC-MS, Nucleoside analogue, Determination.

GS-441524, a nucleoside analogue molecule, is both intermediate and metabolite of remdesivir. Because of proved effectiveness in animals, GS-441524 is expected to be a better potential drug than remdesivir in the treatment of Covid-19. Since GS-441524 is not easily soluble in pure water, polyethylene glycol (PEG) was used as the auxiliary solvent. The developed LC-MS method utilized a UHPLC coupled with a TOF mass spectrometer and developed a gradient elution to efficiently separate GS-441524 and other PEG-400 molecules. The chromatographic separation completed within 6 minutes. GS-441524 was identified in peak at 0.9 min explicitly. No interferent was co-eluted. UV detection was not proved suitable for the determination of GS-441524 under this condition. The correlation coefficient R² (0.9970) indicated a good linear relationship in range of 0.1 ~ 10 μg/mL. The LOD and LOQ of the method was 0.05μg/mL and 0.1 μg/mL respectively. A concrete sample was accuracy analyzed. The developed LC-MS method provided a simple, rapid, accurate and precise analysis protocol for the determination of GS-441524 in preparation system with PEG-400 and water as solvent.

https://doi.org/10.31871/IJNTR.8.11.5