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Application of silica-bonded ovomucoin protein chiral stationary phase for the determination of paroxetine, clinically used psychotropic drug

Anna Jończyk 1Agnieszka Ocios-Bębenek 1Małgorzata Kantor-Boruta Małgorzata Lisowska Kuźmicz 1Małgorzata Jarończyk 1Aleksander P. Mazurek 1,2Zdzisław Chilmonczyk 1

1. Narodowy Instytut Lekow (NIL), Chełmska 30/34, Warszawa 00-725, Poland
2. Medical University of Warsaw, Department of Drug Chemistry, Banacha 1, Warszawa 02-097, Poland

Abstract

Paroxetine {(-)-(3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine]} is an SSRI antidepressant. Marketing of the drug began in 1992 by the pharmaceutical company SmithKlineBeecham. The effectiveness of paroxetine in major depressive disorder has been proven by six placebo-controlled clinical trials [1, 2]. Since in medicinal products beside (-)-trans-paroxetine  its probably inactive enantiomer [3] may be present, appropriate analytical procedures are necessary to determine a content of the second enantiomer (which in best case could be devoid of any pharmacological activity but very often may be responsible for serious adverse effects).

Here we report validated analytical procedure enabling determination of (+/-)-trans-paroxetine  in medicinal products containing (+)-trans-paroxetine as a main active ingredient with the aid silica-bonded ovomucoin protein  chiral stationary phase. Validation included: specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), assay, precision and recovery.

  1. Anderson I.M. Selective serotonin reuptake inhibitors versus tricyclic antidepressants: a meta-analysis of efficacy and tolerability.  J. Affect. Disord. 58, 19-36 (2000).
  2.  Montgomery S.A. A meta-analysis of the efficacy and tolerability of paroxetine versus tricyclic antidepressants in the treatment of major depression. International. Clin. Psychopharmacol. 16, 169-78 (2001).
  3. Segura M., Roura L., de la Torre R., Joglar J.; Synthesis of the major metabolites
    of paroxetine, Bioorg. Chem. 31, 248-258 (2003).
 

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Related papers

Presentation: Poster at VIII Multidyscyplinarna Konferencja Nauki o Leku, by Anna Jończyk
See On-line Journal of VIII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2012-03-14 10:25
Revised:   2012-03-14 10:25