Development of stability indicating method for quality assessment of African Albendazole tablets

In order to assess the quality of Albendazole tablets (Alb) sampled in three countries from West Africa, several physical and chemical tests were performed on tablets at normal conditions. A simple and economic HPLC method has been developed, validated and used for the simultaneous determination of...

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Autores principales:	Hssaine Amine, El Karbane Miloud, Azougagh Mohamed, Houti Imad Eddine, Benaji Brahim
Formato:	article
Lenguaje:	EN FR
Publicado:	EDP Sciences 2021
Materias:	quality stability albendazole tablets monitoring impurities Environmental sciences GE1-350
Acceso en línea:	https://doaj.org/article/e68ece8117d549bd975f88738b6c6184
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spelling	oai:doaj.org-article:e68ece8117d549bd975f88738b6c61842021-11-12T11:44:08ZDevelopment of stability indicating method for quality assessment of African Albendazole tablets2267-124210.1051/e3sconf/202131901084https://doaj.org/article/e68ece8117d549bd975f88738b6c61842021-01-01T00:00:00Zhttps://www.e3s-conferences.org/articles/e3sconf/pdf/2021/95/e3sconf_vigisan_01084.pdfhttps://doaj.org/toc/2267-1242In order to assess the quality of Albendazole tablets (Alb) sampled in three countries from West Africa, several physical and chemical tests were performed on tablets at normal conditions. A simple and economic HPLC method has been developed, validated and used for the simultaneous determination of Albendazole (Alb) content, as well as its impurities and the uniformity of its content. The stability-indicating HPLC method was performed on a Symmetry C18-5µm 250 mm × 4.6 mm column with a gradient elution using a mobile phase composed of acetonitrile and sodium acetate buffer. The flow rate was set at 1 mL.min−1 and the eluent was monitored at 295nm. The method was validated for specificity, linearity, accuracy, precision, robustness and detection and quantification limits, in accordance with International Conference on Harmonisation Quality 2 (ICH Q2) guidelines. This method was performed on different Alb samples (originals and generics) products collected from Senegal, Niger and Mali. The obtained results showed that, the contents of the generic tablets from Niger and Mali comply with the United States Pharmacopeia (USP) monograph acceptance criteria. However, more than 20% of the generic tablets don’t meet the USP monograph impurity limits. In conclusion, the described analytical method is simple, sensitive and accurate. Thus, it could be useful for manufacturing and quality control assays.Hssaine AmineEl Karbane MiloudAzougagh MohamedHouti Imad EddineBenaji BrahimEDP Sciencesarticlequalitystabilityalbendazole tabletsmonitoringimpuritiesEnvironmental sciencesGE1-350ENFRE3S Web of Conferences, Vol 319, p 01084 (2021)
institution	DOAJ
collection	DOAJ
language	EN FR
topic	quality stability albendazole tablets monitoring impurities Environmental sciences GE1-350
spellingShingle	quality stability albendazole tablets monitoring impurities Environmental sciences GE1-350 Hssaine Amine El Karbane Miloud Azougagh Mohamed Houti Imad Eddine Benaji Brahim Development of stability indicating method for quality assessment of African Albendazole tablets
description	In order to assess the quality of Albendazole tablets (Alb) sampled in three countries from West Africa, several physical and chemical tests were performed on tablets at normal conditions. A simple and economic HPLC method has been developed, validated and used for the simultaneous determination of Albendazole (Alb) content, as well as its impurities and the uniformity of its content. The stability-indicating HPLC method was performed on a Symmetry C18-5µm 250 mm × 4.6 mm column with a gradient elution using a mobile phase composed of acetonitrile and sodium acetate buffer. The flow rate was set at 1 mL.min−1 and the eluent was monitored at 295nm. The method was validated for specificity, linearity, accuracy, precision, robustness and detection and quantification limits, in accordance with International Conference on Harmonisation Quality 2 (ICH Q2) guidelines. This method was performed on different Alb samples (originals and generics) products collected from Senegal, Niger and Mali. The obtained results showed that, the contents of the generic tablets from Niger and Mali comply with the United States Pharmacopeia (USP) monograph acceptance criteria. However, more than 20% of the generic tablets don’t meet the USP monograph impurity limits. In conclusion, the described analytical method is simple, sensitive and accurate. Thus, it could be useful for manufacturing and quality control assays.
format	article
author	Hssaine Amine El Karbane Miloud Azougagh Mohamed Houti Imad Eddine Benaji Brahim
author_facet	Hssaine Amine El Karbane Miloud Azougagh Mohamed Houti Imad Eddine Benaji Brahim
author_sort	Hssaine Amine
title	Development of stability indicating method for quality assessment of African Albendazole tablets
title_short	Development of stability indicating method for quality assessment of African Albendazole tablets
title_full	Development of stability indicating method for quality assessment of African Albendazole tablets
title_fullStr	Development of stability indicating method for quality assessment of African Albendazole tablets
title_full_unstemmed	Development of stability indicating method for quality assessment of African Albendazole tablets
title_sort	development of stability indicating method for quality assessment of african albendazole tablets
publisher	EDP Sciences
publishDate	2021
url	https://doaj.org/article/e68ece8117d549bd975f88738b6c6184
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Development of stability indicating method for quality assessment of African Albendazole tablets

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