Enantiomeric separation of the key intermediate of paroxetine using chiral chromatography

Abstract

A selective and reproducible chiral LC method has been developed for the separation and quantification of a key intermediate of paroxetine. The separation was achieved on three different chiral stationary phases, viz Chiralcel OD (250×4.6 mm, 10 μm), Chiralpak AD (250×4.6 mm, 10 μm) and Chiralcel OJ (250×4.6 mm, 10 μm). The method was validated on the Chiralcel OD phase using a mobile phase system consisting of hexane, isopropanol, and diethylamine in the ratio of 96:04:0.3 v/v/v. The precision (% R.S.D.) of the method was found to be less than 1.0 with the percentage recoveries of II B ranged from 96.0 to 103.4. The limits of detection and quantification of II B were found to be 2.0 and 7.5 μg/ml, respectively. The method was linear, with a correlation coefficient greater than 0.990, and the method was proved to be rugged.