title: Chiral HPLC method for chiral purity determination of paroxetine drug substance.
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.
authors.affiliation: GlaxoSmithKline, Analytical Chemistry, Tonbridge, Kent, United Kingdom. Janusz_Zukowski-1@gsk.com
authors.forename: Janusz
authors.initials: J
authors.lastname: Zukowski
authors.forename: Malcolm
authors.initials: M
authors.lastname: Brightwell
authors.forename: Vern
authors.initials: V
authors.lastname: De Biasi
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D017374:Paroxetine / Q000737:chemistry*; D012680:Sensitivity and Specificity; D013237:Stereoisomerism
chemical_list: D018687:Antidepressive Agents, Second-Generation; D017374:Paroxetine