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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/106435
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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 Técnicas2025-09-03T10:03:07Zoai: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:34982025-09-03 10:03:08.01CONICET 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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1842269783812210688 |
score |
13.13397 |