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

Autores
Calvo, Natalia Lorena; Alvarez, Vera Alejandra; Lamas, Maria Celina; Leonardi, Darío
Año de publicación
2019
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Tioconazole, 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 on line quality control and continuous process monitoring of tioconzole 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 tioconzole bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3?95 μm) resolved by microscopic measurements. Tioconazole 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 tioconazole 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 tioconazole 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 on-line process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.
Fil: Calvo, Natalia Lorena. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Alvarez, Vera Alejandra. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mar del Plata. Instituto de Investigaciones en Ciencia y Tecnología de Materiales. Universidad Nacional de Mar del Plata. Facultad de Ingeniería. Instituto de Investigaciones en Ciencia y Tecnología de Materiales; Argentina
Fil: Lamas, Maria Celina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Materia
TIOCONAZOLE
IDENTIFICATION
CHARACTERIZATION
PHARMACEUTICAL DOSAGE FORMS
SPECTROSCOPIC METHODS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/106435
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/106435
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage formsCalvo, Natalia LorenaAlvarez, Vera AlejandraLamas, Maria CelinaLeonardi, DaríoTIOCONAZOLEIDENTIFICATIONCHARACTERIZATIONPHARMACEUTICAL DOSAGE FORMSSPECTROSCOPIC METHODShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Tioconazole, 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 on line quality control and continuous process monitoring of tioconzole 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 tioconzole bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3?95 μm) resolved by microscopic measurements. Tioconazole 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 tioconazole 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 tioconazole 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 on-line process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.Fil: Calvo, Natalia Lorena. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Alvarez, Vera Alejandra. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mar del Plata. Instituto de Investigaciones en Ciencia y Tecnología de Materiales. Universidad Nacional de Mar del Plata. Facultad de Ingeniería. Instituto de Investigaciones en Ciencia y Tecnología de Materiales; ArgentinaFil: Lamas, Maria Celina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaElsevier2019-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/106435Calvo, Natalia Lorena; Alvarez, Vera Alejandra; Lamas, Maria Celina; Leonardi, Darío; New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms; Elsevier; Journal of Pharmaceutical Analysis; 9; 1; 2-2019; 40-482095-1779CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S209517791830251Xinfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.jpha.2018.11.006info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:19:40Zoai:ri.conicet.gov.ar:11336/106435instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:19:41.211CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
title New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
spellingShingle New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
Calvo, Natalia Lorena
TIOCONAZOLE
IDENTIFICATION
CHARACTERIZATION
PHARMACEUTICAL DOSAGE FORMS
SPECTROSCOPIC METHODS
title_short New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
title_full New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
title_fullStr New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
title_full_unstemmed New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
title_sort New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
dc.creator.none.fl_str_mv Calvo, Natalia Lorena
Alvarez, Vera Alejandra
Lamas, Maria Celina
Leonardi, Darío
author Calvo, Natalia Lorena
author_facet Calvo, Natalia Lorena
Alvarez, Vera Alejandra
Lamas, Maria Celina
Leonardi, Darío
author_role author
author2 Alvarez, Vera Alejandra
Lamas, Maria Celina
Leonardi, Darío
author2_role author
author
author
dc.subject.none.fl_str_mv TIOCONAZOLE
IDENTIFICATION
CHARACTERIZATION
PHARMACEUTICAL DOSAGE FORMS
SPECTROSCOPIC METHODS
topic TIOCONAZOLE
IDENTIFICATION
CHARACTERIZATION
PHARMACEUTICAL DOSAGE FORMS
SPECTROSCOPIC METHODS
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Tioconazole, 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 on line quality control and continuous process monitoring of tioconzole 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 tioconzole bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3?95 μm) resolved by microscopic measurements. Tioconazole 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 tioconazole 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 tioconazole 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 on-line process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.
Fil: Calvo, Natalia Lorena. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Alvarez, Vera Alejandra. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mar del Plata. Instituto de Investigaciones en Ciencia y Tecnología de Materiales. Universidad Nacional de Mar del Plata. Facultad de Ingeniería. Instituto de Investigaciones en Ciencia y Tecnología de Materiales; Argentina
Fil: Lamas, Maria Celina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
description Tioconazole, 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 on line quality control and continuous process monitoring of tioconzole 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 tioconzole bulk powder showed a high crystallinity, as observed by XRD, with a particles size distribution (3?95 μm) resolved by microscopic measurements. Tioconazole 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 tioconazole 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 tioconazole 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 on-line process analysis, because they do not require sample preparation, and they are considerably sensitive to analyze complex samples.
publishDate 2019
dc.date.none.fl_str_mv 2019-02
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/106435
Calvo, Natalia Lorena; Alvarez, Vera Alejandra; Lamas, Maria Celina; Leonardi, Darío; New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms; Elsevier; Journal of Pharmaceutical Analysis; 9; 1; 2-2019; 40-48
2095-1779
CONICET Digital
CONICET
url http://hdl.handle.net/11336/106435
identifier_str_mv Calvo, Natalia Lorena; Alvarez, Vera Alejandra; Lamas, Maria Celina; Leonardi, Darío; New approaches of identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms; Elsevier; Journal of Pharmaceutical Analysis; 9; 1; 2-2019; 40-48
2095-1779
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S209517791830251X
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jpha.2018.11.006
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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