Assay of famotidine in API and dosage forms by UV direct and UV derivative spectrophotometric methods

Simple and sensitive UV absorption spectrophotometric method (Method-A) and UV first and second derivative spectrophotometric methods (Method-B and Method-C) have been developed for the estimation of Famotidine (FMD) in pure and its pharmaceutical dosage forms. The wavelength of maximum absorbance was found to be 287.0nm from the absorption spectrum of FMD in methanol. First and second derivative spectra were obtained and from the first derivative spectrum it is found that a valley at 272.2nm has maximum amplitude and therefore validation in Method-B was carried out by measuring the amplitudes at this wavelength. Second derivative spectrum has the maximum amplitude in negative valley at 287.0nm hence the Method-C was validated by measuring amplititudes at 287.0nm. Precision was presented as standard deviation and percent of relative standard deviation of six replicate measurements and found to be within the limits. Accuracy (the mean percent of recovery of triplicate measurements) at three different concentrations i.e. 50%, 100% and 150% of target concentration was calculated and found to be within the range 98.2%-99.8%. A study of proportionality between concentration of the drug and response of the instrument was carried out and found to be linear within the range of concentrations 4-12μg/mL of FMD. Slope, intercept and correlation coefficient were calculated form the linear regression analysis and the correlation coefficient was found to be 0.9999. The developed methods were found to be precise, accurate, stable and robust therefore readily adapted for routine quality control of FMD by ordinary laboratories. The developed methods were effective for estimation of FMD in bulk and pharmaceutical preparations without any interference of other constitute in tablets of different brand names.

Author(s): T. Vijaya Bhaskara Reddy

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