Development and validation of a stability indicating HPTLC-densitometric method for lafutidine

Abstract

Background: A simple, selective, precise, and stability indicating high-performance thin layer chromatographic method has been established and validated for analysis of lafutidine in bulk drug and formulations. Materials and Methods: The compounds were analyzed on aluminum backed silica gel 60 F 254 plates with chloroform:ethanol:acetic Acid (8:1:1) as mobile phase. Densitometric analysis of lafutidine was performed at 230 nm. Result : Regression analysis data for the calibration plots were indicative of good linear relationship between response and concentration over the range 100-500 ng per spot. The correlation coefficient (r 2 ) was 0.998±0.002. Conclusion: Lafutidine was subjected to acid, base, peroxide, and sunlight degradation. In stability tests, the drug was susceptible to acid and basic hydrolysis, oxidation, and photodegradation.