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Chiral HPLC method for chiral purity determination of paroxetine drug substance
Author(s) -
Zukowski Janusz,
Brightwell Malcolm,
de Biasi Vern
Publication year - 2003
Publication title -
chirality
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.43
H-Index - 77
eISSN - 1520-636X
pISSN - 0899-0042
DOI - 10.1002/chir.10250
Subject(s) - chemistry , paroxetine , chromatography , high performance liquid chromatography , drug , chiral derivatizing agent , chiral column chromatography , chiral stationary phase , pharmacology , biochemistry , serotonin , medicine , receptor
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. Chirality 15:600–604, 2003. © 2003 Wiley‐Liss, Inc.