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Abstract

A simple, sensitive, highly accurate method has been developed for the determination of Lafutidine in bulk sample and dosage forms. This method is based on the oxidative coupling reaction of drug with 3-methyl-2-benzothialinone hydrazine hydrochloride (MBTH) reagent in the presence of ferric chloride to form green colored chromogen exhibiting maximum absorption at 630 nm. Beer's law was obeyed and quantitative results were obtained in the range of 1-18µg/mL. The results of the analysis for the methods have been validated statistically. INTRODUCTION: Lafutidine, a newly developed histamine H(2)-receptor antagonist, inhibits gastric acid secretion. It is currently marketed in Japan, China and India. It is not only suppresses gastric acid secretion, but also possesses cytoprotective properties. After oral administration, Lafutidine is quickly absorbed in the GIT. The plasma protein binding ability of Lafutidine is 88%. The drug is predominantly metabolized via CYP2D6 and CYP3A4 enzymes.