Development And Validation of Stability Indicating HPLC Method For Determination of Famotidine and Its Related Substances In Tablet Dosage Form

Abstract

Famotidine is a competitive histamine H-receptor antagonist (H2RA) that binds to the H-receptors located on the basolateral membrane of the parietal cell in the stomach, effectively blocking histamine actions. Its pharmacologic activity results in the inhibition of gastric secretion by suppressing acid concentration and volume of gastric secretion. Famotidine inhibits both basal and nocturnal gastric acid secretion as well as reduces gastric volume, acidity. Famotidine is used to treat and prevent ulcers in stomach and intestine. It also treats conditions in which the stomach produces too much acids, such as Zollinger-Ellison Syndrome. HPLC method was developed & validated for estimation of Famotidine tablet dosage form by using Inertsil ODS (250 mm × 4.6 mm) 5μm column, 1.2 mL/min flow rate, 20μL Injection volume, 40˚C column temp. at 275 nm wavelength. The stability of Famotidine was determined by forced degradation study at different environmental condition. The conditions for forced degradation were acidic, basic, humidity, UV, thermal, oxidative which helps to drug degradation at certain levels. The linearity of detector response was observed for known impurities and Famotidine over the range of LOQ to 150%. The developed method was validated as per the ICH guideline.