Identification and Quantification by NMR Spectroscopy of the 22 R and 22 S Epimers in Budesonide Pharmaceutical Forms

The authors developed four variants of the qNMR technique ( H or C nucleus, DMSO-d6 or CDCl solvent) for identification and quantification by NMR of 22 and 22 epimers in budesonide active pharmaceutical ingredient and budesonide drugs (sprays, capsules, tablets). The choice of the qNMR technique ver...

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Bibliographic Details
Published in:Molecules (Basel, Switzerland) Switzerland), 2022-03, Vol.27 (7)
Main Authors: Kuz'mina, Natalia E, Moiseev, Sergey V, Severinova, Elena Y, Stepanov, Evgenii A, Bunyatyan, Natalia D
Format: Article
Language:English
Subjects:
Budesonide - chemistry
Glucocorticoids
Magnetic Resonance Spectroscopy
Pharmaceutical Preparations
Stereoisomerism
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Summary:The authors developed four variants of the qNMR technique ( H or C nucleus, DMSO-d6 or CDCl solvent) for identification and quantification by NMR of 22 and 22 epimers in budesonide active pharmaceutical ingredient and budesonide drugs (sprays, capsules, tablets). The choice of the qNMR technique version depends on the drug excipients. The correlation of H and C spectra signals to molecules of different budesonide epimers was carried out on the basis of a comprehensive analysis of experimental spectral NMR data ( H- H gCOSY, H- C gHSQC, H- C gHMBC, H- H ROESY). This technique makes it possible to identify budesonide epimers and determine their weight ratio directly, without constructing a calibration curve and using any standards. The results of measuring the 22 epimer content by qNMR are comparable with the results of measurements using the reference HPLC method.
ISSN:1420-3049