Reverse Phase High performance Liquid Chromatography was developed for separation and quantification of entacapone from 1-[2-Cyano-3-(3,4-dihydroxy-5-nitropheyl-1-oxo-2-propenyl piperidine (entacapone Stage IV), (2Z)-2-Cyano-3-(3,4-Dihydroxy-5-Nitrophenyl)-N,NDiethylpropenamide (entacapone Z- form) impurities. The proposed method meets all the requirements of validation and found to be specific, precise, linear, accurate, rugged and robust. Therefore the method can be used as a routine quality control method for quantitative estimation of Stage IV impurity and Z-isomer impurity in entacapone formulated form.
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