Valdecoxib stability properties under forced degradation conditions

Abstract

The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.