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Chiral HPLC method for chiral purity determination of paroxetine drug substance
Janusz Zukowski1, Malcolm Brightwell, Vern De Biasi
1GlaxoSmithKline, Analytical Chemistry, Tonbridge, Kent, United Kingdom. Janusz_Zukowski-1@gsk.com
Abstract:
This article describes a chiral HPLC method for (+) trans isomer of paroxetine in a paroxetine drug substance. The method development was performed to establish a suitable HPLC system in order to separate both enantiomers. It was found that a system based on a Chiralpak AD column was suitable for the analysis. Proper column maintenance and the optimized eluent composition allowed good reproducibility and sensitivity for the method. The method was also checked on a number of different columns using different HPLC equipment and gave both reproducible chromatography and reproducible quantitative results.
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