Method Validation and Quantitative Determination of Famotidine in Human Plasma

A simple, selective and accurate reversed-phase high pressure liquid chromatogaphic method with UV detection at 274 nm has been developed for the determination of famotidine in human plasma. The procedure employed ranitidine as an internal standard (IS). A good chromatographic separation between famotidine, internal standard and interfering endogenous peaks was achieved using a a C18 column and mixture of 0.1% triethylamine:phosphate buffer pH 6.8:acetonitrile (70:15:15% v/v/v) as mobile phase at a flow rate of 1.0 ml/ min. The extraction procedure for RP-HPLC quantitation of famotidine was performed. The method involved reproducible liquid-liquid extraction of drug from biological matrix using a mixture of isopropanol:hexane (1:1). The method was validated with respect of specificity, accuracy and precision over a linear range of 4 – 40 μg/ml for famotidine. The LOQs and LODs were 1.0 and 0.2 μg/ml, respectively.