RP-HPLC determination of famotidine and its potential impurities in pharmaceuticals

A simple, sensitive, and rapid reversed-phase high-performance liquid chromatographic method has been developed for determination of famotidine (FMT) and its impurities in pharmaceutical formulations. Separations were performed on a Supelcosil LC18 column with an isocratic mobile phase-13:87 (v/v) acetonitrile-0.1 (M) dihydrogen phosphate buffer containing 0.2% triethylamine (pH 3.0). The mobile phase flow rate was 1 mL min(-1) and the detection wavelength was 265 nm. Response was linearly dependent on concentration between 1 and 80 mug mL(-1) (regression coefficient, R-2, from 0.9981 to 0.9999). RSD from determination of method repeatability (intraday) and reproducibility (interday) were < 2% (n = 6). Lowest detectable concentrations ranged from 0.08 to 0.14 mug mL(-1). The proposed liquid chromatographic method can be satisfactorily used for routine quality control of famotidine in pharmaceutical formulations.