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The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations |
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| Authors: | Kenan Can Tok Mehmet Gumustas Giorgi Jibuti Halit Sinan Suzen Sibel A. Ozkan Bezhan Chankvetadze |
| Affiliation: | 1.Department of Forensic Toxicology, Institute of Forensic Sciences, Ankara University, Ankara 06590, Turkey; (K.C.T.); (M.G.); (H.S.S.);2.Institute of Physical and Analytical Chemistry, School of Exact and Natural Sciences, Tbilisi State University, Chavchavadze Ave 3, 0179 Tbilisi, Georgia;3.Department of Pharmaceutical Toxicology, Faculty of Pharmacy, Ankara University, Ankara 06560, Turkey;4.Department of Analytical Chemistry, Faculty of Pharmacy, Ankara University, Ankara 06560, Turkey; |
| Abstract: | 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% (w/w). |
| Keywords: | enantiomeric impurity determination amylose tris(3-chloro-5-methylphenylcarbamate) enantiomer elution order reversal method validation dexketoprofen |