ISSN: 2639-2534
Authors: Redasani VK*, Agrawal YO, Jagtap MS, Mahajan HS and Surana SJ
The aim of the present work is to establish three simple, economical and rapid methods for the quantification of Flecainide acetate in bulk drug and in tablets formulation. This study is designed to validate and developed spectroscopic and chromatographic methods as per ICH guidelines. In Method A, area under curve (AUC) of zero-order spectrum was recorded between 277.00 and 310.00nm. Linearity was found in the concentration range of 20-120μg/ml. In Method B, zero-order spectra were derivatized into first-order and the AUC was recorded between 280.00 and 310.20 nm. The linearity was found in the conc. range of 20-120μg/ml. In Method C, separation was achieved using RP-HPLC by gradient elution using a C18 Qualisil BDS (250mm×4.5mm×5μm) column, a mobile phase consisting of water: acetonitrile (60:40 v/v) with mobile phase pH adjusted with orthophosphoric acid (pH 3.0), a flow rate of 1.0ml/min and UV detection at 296nm. The linearity was obtained in the concentration range of 10-50μg/ml. The developed methods are validated successfully across various parameters in accordance with ICH guidelines. Thus, the proposed methods can be used for routine analysis of Flecainide acetate as it does not showed any interference of excipients when estimated in pharmaceutical formulations.
Keywords: Flecainide Acetate; Spectrophotometric; Chromatographic; Area Under Curve; Derivative-Spectrophotometry; Validation; ICH Guidelines
