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