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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.
- Source :
-
Molecules (Basel, Switzerland) [Molecules] 2020 Dec 11; Vol. 25 (24). Date of Electronic Publication: 2020 Dec 11. - Publication Year :
- 2020
-
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 ).
- Subjects :
- Calibration
Chemistry Techniques, Analytical
Chemistry, Pharmaceutical
Chromatography
Drug Compounding
Drug Contamination
Ketoprofen chemistry
Limit of Detection
Reproducibility of Results
Stereoisomerism
Amylose chemistry
Chromatography, High Pressure Liquid methods
Ketoprofen analogs & derivatives
Phenylcarbamates chemistry
Tromethamine chemistry
Subjects
Details
- Language :
- English
- ISSN :
- 1420-3049
- Volume :
- 25
- Issue :
- 24
- Database :
- MEDLINE
- Journal :
- Molecules (Basel, Switzerland)
- Publication Type :
- Academic Journal
- Accession number :
- 33322449
- Full Text :
- https://doi.org/10.3390/molecules25245865