The Effect of Enantiomer Elution Order on the Determination of Minor Enantiomeric Impurity in Ketoprofen and Enantiomeric Purity Evaluation of Commercially Available Dexketoprofen Formulations
| Autor: | Giorgi Jibuti, Mehmet Gumustas, Bezhan Chankvetadze, Sibel A. Ozkan, Kenan Can Tok, Halit Sinan Süzen |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Ketoprofen
Chemistry Pharmaceutical Drug Compounding Phenylcarbamates Pharmaceutical Science enantiomeric impurity determination 02 engineering and technology 01 natural sciences Chemistry Techniques Analytical Article Analytical Chemistry lcsh:QD241-441 lcsh:Organic chemistry Limit of Detection Impurity Drug Discovery medicine Tromethamine Physical and Theoretical Chemistry dexketoprofen Chromatography High Pressure Liquid amylose tris(3-chloro-5-methylphenylcarbamate) Chromatography Elution Chemistry 010401 analytical chemistry Organic Chemistry Reproducibility of Results method validation Stereoisomerism 021001 nanoscience & nanotechnology Dexketoprofen 0104 chemical sciences Chemistry (miscellaneous) Calibration enantiomer elution order reversal Molecular Medicine Amylose Enantiomer Drug Contamination 0210 nano-technology medicine.drug |
| Zdroj: | Molecules Volume 25 Issue 24 Molecules, Vol 25, Iss 5865, p 5865 (2020) |
| ISSN: | 1420-3049 |
| DOI: | 10.3390/molecules25245865 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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