Abstract
The kinetics of hydrolysis of famotidine were studied in 0.01–0.10 M hydrochloric acid solutions of 2 mg/ml using a stability-indicating high-performance liquid Chromatographic assay with ultraviolet detection. The hydrolysis followed pseudo-first order kinetics with respect to famotidine concentration. The observed rate constant was found to depend on hydrogen ion concentration and was not influenced by the ionic strength. The specific hydrogen ion catalytic rate constant was calculated to be 3.427 M −1· h −1 at 37° C. The temperature dependence of famotidine hydrolysis was investigated in 0.1 M hydrochloric acid solutions having an ionic strength of 0.2 in the temperature range 37–55° C. The activation energy was determined to be 63.7 kJ/mol. The impact of the acid-catalyzed hydrolysis on the stability of famotidine in the stomach was discussed. It was estimated that in the gastric pH 1–2 and with a gastric emptying half-life of 50 min in normal young adults about 5.3–35.8% of an oral dose of famotidme would undergo degradation in the stomach. This percentage might be even increased to 12.0–57.8% in the elderly.
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