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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Tok K. C., Gümüştaş M., Jibuti G., Süzen H. S., Özkan S. A., Chankvetadze B.

MOLECULES, cilt.25, sa.24, 2020 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 25 Sayı: 24
  • Basım Tarihi: 2020
  • Doi Numarası: 10.3390/molecules25245865
  • Dergi Adı: MOLECULES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aerospace Database, Agricultural & Environmental Science Database, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Communication Abstracts, EMBASE, MEDLINE, Metadex, Veterinary Science Database, Directory of Open Access Journals, Civil Engineering Abstracts
  • Anahtar Kelimeler: enantiomeric impurity determination, amylose tris(3-chloro-5-methylphenylcarbamate), enantiomer elution order reversal, method validation, dexketoprofen, PERFORMANCE LIQUID-CHROMATOGRAPHY, CHIRAL STATIONARY PHASES, HPLC SEPARATION, SCALE ISOLATION, REVERSAL, CELLULOSE, EMPHASIS, COLUMNS, DRUGS, RETENTION
  • Ankara Üniversitesi Adresli: Evet

Özet

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).