Thermal Degradation of Famotidine in Aqueous Solution Stability Indicating Assay

Abstract
A High Pressure Liquid Chromatographic Method is described for the determination of famotidine in aqueous solution. The assay method is capable of distinguishing famotidine from its thermal degradation products in the pH range of 1.7–10.0. Famotidine and the internal standard sulfacetamide eluted in 13 minutes with retention times of 10 and 5.7, respectively. A linear relationship between peak height ratio (famotidine/sulfacetamide) and famotidine concentration was found up to 60 μg/ml. The coefficient of variation of the assay method over several days ranged from 0.2 to 5.1% in the concentration range of 4–57 μg/ml.