Simultaneous enantio- and diastereo-selective high-performance liquid chromatography separation of paroxetine on an immobilized amylose-based chiral stationary phase under green reversed-phase conditions.

A simple and green high-performance liquid chromatography method for the separation of paroxetine from its enantiomeric and diastereomeric impurities has been developed. The simultaneous chromatographic resolution was carried out on the amylose-based Chiralpak IA-3 chiral stationary phase using the mixture ethanol-water-diethylamine 80:20:0.1 (v/v/v) as a mobile phase. The effects of substitution of ethanol with methanol or acetonitrile and changes in column temperature on selectivity have been carefully investigated. The optimized single-run HPLC protocol allows the baseline separation of the enantiomers of paroxetine without suffering from interference from five other chiral and achiral impurities reported in the monograph of the European Pharmacopoeia.