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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF FAMOTIDINE IN BULK AND ITS TABLET DOSAGE FORM BY RP-HPLC

P. Sandhya Rani*, G. Naga Sowjanya, A. Ajitha, Dr. V. Uma Maheswara Rao

ABSTRACT

A simple, precise, reliable, specific and accurate Reverse phase high performance liquid chromatography method was developed for estimation of Famotidine in bulk and in it’s tablet dosage form was carried out on a BDS C8 (4.6×250mm) 5μ column using a mixture of Methanol: buffer pH3 (80:20) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 288nm. The retention time of the Famotidine was 3.7min. The method produced linear responses in the concentration range of 20-100μg/ml of Famotidine. The correlation coefficient of Famotidine was found to be 0.996. The method precision for the determination of assay was below 2.0% RSD. The LOD values for Famotidine were found 1.303μg/mL. The LOQ values for Famotidine were found 3.95μg/mL. The method can be used for the quality analysis of bulk and pharmaceutical formulations.

Keywords: Famotidine, RP-HPLC, validation, BDS, LOD, LOQ, %RSD.


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