New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms
Tioconazole (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 characterizatio...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2019-02-01
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| Series: | Journal of Pharmaceutical Analysis |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S209517791830251X |
| _version_ | 1818648415641272320 |
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| author | Natalia L. Calvo Vera A. Alvarez María C. Lamas Darío Leonardi |
| author_facet | Natalia L. Calvo Vera A. Alvarez María C. Lamas Darío Leonardi |
| author_sort | Natalia L. Calvo |
| collection | DOAJ |
| description | Tioconazole (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. Keywords: Tioconazole, Identification, Characterization, Pharmaceutical dosage forms, Spectroscopic methods |
| first_indexed | 2024-12-17T01:18:04Z |
| format | Article |
| id | doaj.art-073ee72b1c314966a7773a56ec80177f |
| institution | Directory Open Access Journal |
| issn | 2095-1779 |
| language | English |
| last_indexed | 2024-12-17T01:18:04Z |
| publishDate | 2019-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Pharmaceutical Analysis |
| spelling | doaj.art-073ee72b1c314966a7773a56ec80177f2022-12-21T22:08:55ZengElsevierJournal of Pharmaceutical Analysis2095-17792019-02-01914048New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage formsNatalia L. Calvo0Vera A. Alvarez1María C. Lamas2Darío Leonardi3Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina; Área Análisis de Medicamentos, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, Argentina; Corresponding authors at: Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina.Grupo de Materiales Compuestos Termoplásticos (CoMP), Instituto de Investigaciones de Ciencia y Tecnología de Materiales (INTEMA, CONICET-UNMdP), Colón 10890, Mar del Plata 7600, ArgentinaInstituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina; Área Técnica Farmacéutica, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, ArgentinaInstituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina; Área Técnica Farmacéutica, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, Argentina; Corresponding authors at: Instituto de Química Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina.Tioconazole (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. Keywords: Tioconazole, Identification, Characterization, Pharmaceutical dosage forms, Spectroscopic methodshttp://www.sciencedirect.com/science/article/pii/S209517791830251X |
| spellingShingle | Natalia L. Calvo Vera A. Alvarez María C. Lamas Darío Leonardi New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms Journal of Pharmaceutical Analysis |
| title | New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| title_full | New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| title_fullStr | New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| title_full_unstemmed | New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| title_short | New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| title_sort | new approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms |
| url | http://www.sciencedirect.com/science/article/pii/S209517791830251X |
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