Stability-Indication LC Determination of Entacapone in Tablets

Abstract

A rapid and sensitive RP-HPLC method with UV detection at 305 nm for routine quality control of entacapone in tablets was developed. The procedure was validated by specificity, robust-ness, linearity, accuracy, repeatability and intermediate precision. Experimental design was used during validation to calculate method robustness. The method employs an Ace RP-18 (250 · 4.6 mm i.d., particle size 5 lm), with a mobile phase consisting of water pH 3.0: acetonitrile (65:35, v/v). Entacapone solutions were exposed to direct UV radiation (254 nm), alkaline hydrolysis, acid hydrolysis and effect of oxidation by hydrogen peroxide to evaluate method stability-indication and peak purity tool was utilized to verify the peak purity. The results confirm that the method is highly suitable for its intended purpose. Keywords Column liquid chromatography Experimental design Validation and stability Entacapone in tablet