Enantiomeric separation of the key intermediate of paroxetine using chiral chromatography.

摘要

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 (250x4.6 mm, 10 microm), Chiralpak AD (250x4.6 mm, 10 microm) and Chiralcel OJ (250x4.6 mm, 10 microm). 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 microg/ml, respectively. The method was linear, with a correlation coefficient greater than 0.990, and the method was proved to be rugged.