Purity determination of a new antifungal drug candidate using quantitative 1 H NMR spectroscopy : Method validation and comparison of calibration approaches

© 2019 John Wiley & Sons, Ltd.

Bibliographische Detailangaben
Veröffentlicht in:Magnetic resonance in chemistry : MRC. - 1985. - 58(2020), 1 vom: 15. Jan., Seite 97-105
1. Verfasser: Franco, Pedro Henrique Cavalcanti (VerfasserIn)
Weitere Verfasser: Braga, Saulo Fehelberg Pinto, de Oliveira, Renata Barbosa, César, Isabela Costa
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2020
Zugriff auf das übergeordnete Werk:Magnetic resonance in chemistry : MRC
Schlagworte:Comparative Study Journal Article Research Support, Non-U.S. Gov't 1H 2-thiazolylhydrazone NMR analytical chemistry antifungal drug development quantitative NMR mehr... spectroscopy Acetanilides Antifungal Agents Thiazoles acetanilide SP86R356CC
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520 |a Quantitative nuclear magnetic resonance (qNMR) is an analytical technique that offers numerous advantages in pharmaceutical applications including minimum sample preparation and rapid data collection times with no need for response factor corrections, being a powerful tool for assaying drug content in both drug discovery and early drug development. In the present work, we have applied qNMR, using both the internal standard and the electronic reference to access in vivo concentrations 2 calibration methods, to assess the purity of RI76, a novel antifungal drug candidate. NMR acquisition and processing parameters were optimized in order to obtain spectra with intense, well-resolved signals of completely relaxed nuclei. The analytical method was validated following current guidelines, demonstrating selectivity, linearity, accuracy, precision, and robustness. The calibration approaches were statistically compared, and no significant difference was observed when comparing the obtained results and their dispersion in terms of relative standard deviation. The proposed qNMR method may, therefore, be used for both qualitative and quantitative assessments of RI76 in early drug development and for characterization of this compound 
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650 4 |a 2-thiazolylhydrazone 
650 4 |a NMR 
650 4 |a analytical chemistry 
650 4 |a antifungal 
650 4 |a drug development 
650 4 |a quantitative NMR 
650 4 |a spectroscopy 
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650 7 |a Thiazoles  |2 NLM 
650 7 |a acetanilide  |2 NLM 
650 7 |a SP86R356CC  |2 NLM 
700 1 |a Braga, Saulo Fehelberg Pinto  |e verfasserin  |4 aut 
700 1 |a de Oliveira, Renata Barbosa  |e verfasserin  |4 aut 
700 1 |a César, Isabela Costa  |e verfasserin  |4 aut 
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