Development and Validation of Stability Indicating RP-HPLC Method For Flecainide Acetate In Tablet Dosage Form and Forced Degradation Study By QBD Approach

Abstract

RP-HPLC method has been developed for assessment of Flecainide Acetate by applying QbD approaches on a Waters C18, 250mm X 4.6 mm, 5μm with UV detection at 298 nm. The studies elaborate optimization of forced degradation conditions and development of a stability-indicating assay method for flecainide acetate employing the DOE. The optimization of forced degradation conditions, specifically acidic, basic and oxidative, was done by application of Central Composite designs, which helped to obtain 10-30% drug degradation and developed levels of degradation products. The study showed the degradation behavior of the drug in different forced degradation conditions, too. The predicted optimization condition done by Phosphate Buffer pH 5 (Add 750μL Phosphoric acid in 530 ml HPLC grade Water and add 530 μL TEA in it, pH adjusted with 10% KOH) and Acetonitrile 55:45 (v/v) with 1.0 ml/min flow rate. The detector response was linear in the concentration of 100 – 300 μg/mL with LOD 0.2 μg/mL and LOQ 0.7 μg/mL. The developed method was validated as per ICH guidelines.