The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations

In a recent study, opposite enantiomer elution order was observed for ketoprofen enantiomers on two amylose-phenylcarbamate-based chiral columns with the same chemical composition of the chiral selector but in one case with coated while in the other with an immobilized chiral selector. In the presen...

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Main Authors: Kenan Can Tok, Mehmet Gumustas, Giorgi Jibuti, Halit Sinan Suzen, Sibel A. Ozkan, Bezhan Chankvetadze
Format: Article
Language:English
Published: MDPI AG 2020-12-01
Series:Molecules
Subjects:
Online Access:https://www.mdpi.com/1420-3049/25/24/5865
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spelling doaj-655da5fa64654fe18baba9488d9b83532020-12-12T00:03:31ZengMDPI AGMolecules1420-30492020-12-01255865586510.3390/molecules25245865The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen FormulationsKenan Can Tok0Mehmet Gumustas1Giorgi Jibuti2Halit Sinan Suzen3Sibel A. Ozkan4Bezhan Chankvetadze5Department of Forensic Toxicology, Institute of Forensic Sciences, Ankara University, Ankara 06590, TurkeyDepartment of Forensic Toxicology, Institute of Forensic Sciences, Ankara University, Ankara 06590, TurkeyInstitute of Physical and Analytical Chemistry, School of Exact and Natural Sciences, Tbilisi State University, Chavchavadze Ave 3, 0179 Tbilisi, GeorgiaDepartment of Forensic Toxicology, Institute of Forensic Sciences, Ankara University, Ankara 06590, TurkeyDepartment of Analytical Chemistry, Faculty of Pharmacy, Ankara University, Ankara 06560, TurkeyInstitute of Physical and Analytical Chemistry, School of Exact and Natural Sciences, Tbilisi State University, Chavchavadze Ave 3, 0179 Tbilisi, GeorgiaIn a recent study, opposite enantiomer elution order was observed for ketoprofen enantiomers on two amylose-phenylcarbamate-based chiral columns with the same chemical composition of the chiral selector but in one case with coated while in the other with an immobilized chiral selector. In the present study, the influence of this uncommon effect on method validation parameters for the determination of minor enantiomeric impurity in dexketoprofen was studied. The validated methods with two alternative elution orders for enantiomers were applied for the evaluation of enantiomeric impurity in six marketed dexketoprofen formulations from various vendors. In most of these formulations except one the content of enantiomeric impurity exceeded 0.1% (<i>w</i>/<i>w</i>).https://www.mdpi.com/1420-3049/25/24/5865enantiomeric impurity determinationamylose tris(3-chloro-5-methylphenylcarbamate)enantiomer elution order reversalmethod validationdexketoprofen
collection DOAJ
language English
format Article
sources DOAJ
author Kenan Can Tok
Mehmet Gumustas
Giorgi Jibuti
Halit Sinan Suzen
Sibel A. Ozkan
Bezhan Chankvetadze
spellingShingle Kenan Can Tok
Mehmet Gumustas
Giorgi Jibuti
Halit Sinan Suzen
Sibel A. Ozkan
Bezhan Chankvetadze
The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
Molecules
enantiomeric impurity determination
amylose tris(3-chloro-5-methylphenylcarbamate)
enantiomer elution order reversal
method validation
dexketoprofen
author_facet Kenan Can Tok
Mehmet Gumustas
Giorgi Jibuti
Halit Sinan Suzen
Sibel A. Ozkan
Bezhan Chankvetadze
author_sort Kenan Can Tok
title The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
title_short The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
title_full The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
title_fullStr The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
title_full_unstemmed The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
title_sort effect of enantiomer elution order on the determination of minor enantiomeric impurity in ketoprofen and enantiomeric purity evaluation of commercially available dexketoprofen formulations
publisher MDPI AG
series Molecules
issn 1420-3049
publishDate 2020-12-01
description In a recent study, opposite enantiomer elution order was observed for ketoprofen enantiomers on two amylose-phenylcarbamate-based chiral columns with the same chemical composition of the chiral selector but in one case with coated while in the other with an immobilized chiral selector. In the present study, the influence of this uncommon effect on method validation parameters for the determination of minor enantiomeric impurity in dexketoprofen was studied. The validated methods with two alternative elution orders for enantiomers were applied for the evaluation of enantiomeric impurity in six marketed dexketoprofen formulations from various vendors. In most of these formulations except one the content of enantiomeric impurity exceeded 0.1% (<i>w</i>/<i>w</i>).
topic enantiomeric impurity determination
amylose tris(3-chloro-5-methylphenylcarbamate)
enantiomer elution order reversal
method validation
dexketoprofen
url https://www.mdpi.com/1420-3049/25/24/5865
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