An Improved Commercially Feasible Process for Flecainide Acetate
Nilesh Takale
Department of Chemistry, Annamalai University, Annamalai Nagar, Chidambaram, Tamilnadu, India. and Emcure Pharmaceuticals Ltd, Analytical Research Centre, Hinjawadi, Pune-411057, Maharashtra, India.
Neelakandan Kaliyaperumal
Emcure Pharmaceuticals Ltd, Analytical Research Centre, Hinjawadi, Pune-411057, Maharashtra, India.
Gopalakrishnan Mannathusamy
Department of Chemistry, Annamalai University, Annamalai Nagar, Chidambaram, Tamilnadu, India.
Rajarajan Govindasamy *
Department of Chemistry, Annamalai University, Annamalai Nagar, Chidambaram, Tamilnadu, India and Bharathiar University, Coimbatore-641046, Tamilnadu, India.
*Author to whom correspondence should be addressed.
Abstract
Commercially viable manufacturing process for Flecainide Acetate (I) conforming to regulatory specification and cost effective process is reported. Specifically, an improved process for the preparation of Flecainide Acetate allows isolation of anhydrous hydrochloride salt of Compound III, which facilitates the reduction of the pyridine ring with the only catalytic amount of platinum on carbon within 2 hours Therefore, simplifies the synthesis and isolation of Flecainide acetate on a commercial scale to a considerable extent.
Keywords: Cardiac depressant, catalytic hydrogenation, platinum catalyst, antiarrhythmic, boric acid