Development of stability indicating assay method for estimation of Ibuprofen and Famotidine in combined dosage form in tablet

Manoj Charde, Prashant Kurane, Prashant Kurane, Pandurang Dhabale, Pandurang Dhabale

Abstract


A simple, precise, accurate, simultaneous stability indicating RP-HPLC method for the estimation of IBU (Ibuprofen) and FMT (Famotidine) in combined dosage form was developed  using Grace RP-C18 (4.6 x 250mm, 5µm) in an gradient mode with mobile phase comprising  of Methanol: Water (pH 2.5 using OPA) The flow rate was 0.7 mL/ min and effluent was monitored at 240.0 nm. The retention times were found to be 6.68 min for IBU and 1.76 min for FMT. The assay exhibited a linear dynamic range of 30- 150 µg/mL for IBU and 1- 5 µg/mL for FMT. The calibration curves were linear (r2 = 0.994 for IBU and r2 = 0.997 for FMT) over the entire linear range. Mean % recovery was found to be 99.82 % for IBU and 99.91 % for FMT with % RSD was NMT 2 for both estimations which fully agrees with system suitability which is in good agreement with labeled amount of formulation. The % RSD for Intra- Day & Inter-Day Precision was NMT than 2 for both the drugs. The developed method was validated as per ICH guidelines


Keywords


IBU, FMT, RP-HPLC, Assay method, Method Validation

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DOI: http://dx.doi.org/10.7439/ijapa.v5i4.3010

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