title: New validated HPLC methodology for the determination of (-)-trans-paroxetine and its enantiomer in pharmaceutical formulations with use of ovomucoid chiral stationary phase.
abstract: A new chromatographic method for the enantioseparation and the determination of (-)-trans-paroxetine and (+)-trans-paroxetine has been developed with the aid of amylose ovomucoid-based chiral stationary phase. The method is faster and five times more sensitive than procedures recommended previously: limit of detection and limit of quantification are 5 and 16 ng/mL, respectively [modified (Ferretti et al. in J Chromatogr B 710:157-164, 1998): 20 and 60 ng/mL]. It was carefully validated and applied for the determination of (-)-trans-paroxetine and (+)-trans-paroxetine in Parogen (Mc Dermott Laboratories Ltd.) and Xetanor (Actavis) coated tablets.
authors.affiliation: National Medicines Institute, 30/34 Chełmska St, 00-725, Warsaw, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Lisowska-Kuźmicz
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Kantor-Boruta
authors.forename: Anna
authors.initials: A
authors.lastname: Jończyk
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Jarończyk
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Ocios-Bębenek
authors.forename: Aleksander P
authors.initials: AP
authors.lastname: Mazurek
authors.forename: Zdzisław
authors.initials: Z
authors.lastname: Chilmonczyk
authors.forename: Maciej
authors.initials: M
authors.lastname: Jarosz
mesh_terms: D000688:Amylose / Q000737:chemistry*; D018687:Antidepressive Agents, Second-Generation / Q000032:analysis / Q000737:chemistry; D002623:Chemistry Techniques, Analytical; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002845:Chromatography; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D057230:Limit of Detection; D010059:Ovomucin / Q000737:chemistry*; D017374:Paroxetine / Q000032:analysis* / Q000737:chemistry*; D012016:Reference Values; D015203:Reproducibility of Results; D013237:Stereoisomerism; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D013607:Tablets; D010059:Ovomucin; D017374:Paroxetine; D000688:Amylose