Stability Indicating Analytical Method Development, Validation, Method Transfer And Impurity Profile (Related Substances) of 2,4-Dihydroxy-5-Fluoropyrimidine by Liquid Chromatography

Abstract

Uracil, 5-Methoxy Uracil, 5-Chloropyrimidine-2,4(1H,3H)-dione, Dihydropyrimidine-2,4,5(3H)-
trione, and other related chemicals were the subject of a stability-indicating liquid chromatographic method's development. Using a column with dimensions of 250mm × 5μm (YMC
Pack ODS AQ), a flow rate of 1.0 mL/min at a wavelength of 266 nm, an injection volume of 20 μL, and a run period of 30 minutes, validation was carried out on a greater concentration of 2,4-dihydroxy-5-fluoro pyrimidine.