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Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco

In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered prod...

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Autores principales: Bourichi, Houda, Brik, Youness, Hubert, Philipe, Cherrah, Yahia, Bouklouze, Abdelaziz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760925/
https://www.ncbi.nlm.nih.gov/pubmed/29403776
http://dx.doi.org/10.1016/j.jpha.2012.05.007
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author Bourichi, Houda
Brik, Youness
Hubert, Philipe
Cherrah, Yahia
Bouklouze, Abdelaziz
author_facet Bourichi, Houda
Brik, Youness
Hubert, Philipe
Cherrah, Yahia
Bouklouze, Abdelaziz
author_sort Bourichi, Houda
collection PubMed
description In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole.
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spelling pubmed-57609252018-02-05 Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco Bourichi, Houda Brik, Youness Hubert, Philipe Cherrah, Yahia Bouklouze, Abdelaziz J Pharm Anal Article In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. Xi'an Jiaotong University 2012-12 2012-08-17 /pmc/articles/PMC5760925/ /pubmed/29403776 http://dx.doi.org/10.1016/j.jpha.2012.05.007 Text en © 2012 Xi'an Jiaotong University http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
spellingShingle Article
Bourichi, Houda
Brik, Youness
Hubert, Philipe
Cherrah, Yahia
Bouklouze, Abdelaziz
Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title_full Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title_fullStr Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title_full_unstemmed Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title_short Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco
title_sort solid-state characterization and impurities determination of fluconazol generic products marketed in morocco
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760925/
https://www.ncbi.nlm.nih.gov/pubmed/29403776
http://dx.doi.org/10.1016/j.jpha.2012.05.007
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