RP-HPLC method development & validation for estimation of Flecainide acetate in bulk and tablet dosage form


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1

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2

Abstract :

A novel stability indicating liquid chromatographic assay method was developed and validated as per ICH guide lines for the quantitative estimation of Flecainide in tablet formulation. An isocratic reverse phase LC-method was developed using C18 ODS 250cm x 4mm x 5µm particle size column and a mobile phase comprising of a mixture of buffer: acetonitrile (40:60), pH adjusted to 3.0 with Ammonium di-hydrogen phosphate. The detector set at 299nm with flow rate of 1.0ml min-1. The method is linear between 5µg ml-1 to 25µg ml-1 and the limit of detection (LOD) is 0.5 µg ml-1. The Accuracy of the method was found to be in the range of 99.70% to 100.26%. The mean Inter and Intraday assay Relative Standard deviation (% RSD) were less than 0.69%. The Proposed method was found to be Linear, precise and accurate for the quantitative estimation of Flecainide in tablet formulations and can be used for commercial purposes.
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