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Enantiomeric separation of the key intermediate of paroxetine using chiral chromatography
V V Vivekanand1, V Ravi Kumar, Pradeep K Mohakhud
1Analytical Research, Discovery Research, Dr Reddy's Laboratories Ltd, Miyapur, Hyderabad 500050, India.
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 x 4.6 mm, 10 microm), Chiralpak AD (250 x 4.6 mm, 10 microm) and Chiralcel OJ (250 x 4.6 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.
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