New approaches to identification and characterization of tioconazole in raw material and inpharmaceutical dosage forms

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dc.citation.titleJournal of Pharmaceutical Analysis
dc.creatorCalvo, Natalia Lorena
dc.creatorAlvarez, Vera A.
dc.creatorLamas, María Celina
dc.creatorLeonardi, Darío
dc.date.accessioned2024-06-10T17:16:41Z
dc.date.available2024-06-10T17:16:41Z
dc.date.issued2018-11-23
dc.description.abstractTioconazole (TCZ), a broad-spectrum antifungal agent, has significant activity against Candida albicans and other Candida species, and therefore, it is indicated for the topical treatment of superficial mycoses. The main goal of this work is to report an exhaustive identification and characterization procedure to improve and facilitate the online quality control and continuous process monitoring of TCZ in bulk material and loaded in two different dosage forms: ovules and nail lacquer. The methodologies were based on thermal (differential scanning calorimetry (DSC), melting point, and thermogravimetry (TG)), spectroscopic (ultraviolet (UV), Raman, near infrared (NIR), infrared spectroscopy coupled to attenuated total reflectance (FTIR-ATR), and nuclear magnetic resonance (NMR)), microscopic and X-ray diffraction (XRD). The TCZ bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3–95 µm) resolved by microscopic measurements. TCZ melting point (82.8 °C) and a degradation peak centered at 297.8 °C were obtained by DSC and DTG, respectively. An unambiguous structure elucidation of TCZ was obtained by mono- and two- dimensional 1H and 13C NMR spectral data analysis. The FTIR-ATR, Raman and NIR spectra of both the raw material and the commercial products were analyzed and their characteristic bands were tabulated. The best methods for TCZ identification in ovules were DSC, TG, XRD, NIR and Raman, while NIR and FTIR-ATR were the most appropriate techniques to analyze it in the nail lacquer. DSC, TG, DRX, Raman, FTIR-ATR and NIR spectroscopy are effective techniques to be used in online process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.
dc.description.filFil: Calvo, Natalia Lorena. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUR-CONICET); Argentina.
dc.description.filFil: Calvo, Natalia Lorena. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área Análisis Medicamentos; Argentina.
dc.description.filFil: Álvarez, Vera A. Universidad Nacional de Mar del Plata. Centro Científico Tecnológico Mar del Plata. Instituto de Investigaciones de Ciencia y Tecnología de Materiales. Grupo de Materiales Compuestos Termoplásticos (INTEMA-CONICET); Argentina.
dc.description.filFil: Lamas, María Celina. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUR-CONICET); Argentina.
dc.description.filFil: Lamas, María Celina. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área Técnica Farmacéutica; Argentina.
dc.description.filFil: Leonardi, Darío. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUR-CONICET); Argentina.
dc.description.filFil: Leonardi, Darío. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área Técnica Farmacéutica; Argentina.
dc.description.sponsorshipAgencia Nacional de Promoción de Ciencia y Tecnología (ANPCyT)
dc.description.sponsorshipConsejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
dc.description.sponsorshipUniversidad Nacional de Rosario (UNR)
dc.description.versionpeerreviewed
dc.format.extent40-48
dc.identifier.issn2095-1779
dc.identifier.urihttps://hdl.handle.net/2133/27290
dc.language.isoen
dc.publisherElsevier
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S209517791830251X?via%3Dihub
dc.relation.publisherversionhttps://doi.org/10.1016/j.jpha.2018.11.006.
dc.rightsopenAccess
dc.rights.holderCalvo, Natalia Lorena
dc.rights.holderÁlvarez, Vera A.
dc.rights.holderLamas, María Celina
dc.rights.holderLeonardi, Darío
dc.rights.holderUniversidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas
dc.rights.textAttribution-noncomercial-noderivs 4.0 internacional
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectTioconazole
dc.subjectPharmaceutical dosage forms
dc.subjectSpectroscopic methods
dc.subjectIdentification
dc.subjectCharacterization
dc.subjectAntifungal agents
dc.subjectCandida
dc.titleNew approaches to identification and characterization of tioconazole in raw material and inpharmaceutical dosage forms
dc.typearticulo
dc.type.collectionarticulo
dc.type.versionpublishedVersion

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