E3S Web Conf.
Volume 319, 2021International Congress on Health Vigilance (VIGISAN 2021)
|Number of page(s)||6|
|Published online||09 November 2021|
Development of stability indicating method for quality assessment of African Albendazole tablets
1 Biomedical Engineering and Pharmaceuticals Sciences Groupe Research - National Graduate School of Arts and Crafts (ENSAM)- Mohammed V University Rabat, Morocco
2 Group of Bio-pharmaceutical and Toxicology Analysis- Laboratory of Pharmacology and Toxicology, Research Center of Drugs Sciences -Faculty of Medicine and Pharmacy- Mohammed V University, Rabat, Morocco
3 Laboratory of Analytical Chemistry and Bromatology - Research Center of Drugs Sciences -Faculty of Medicine and Pharmacy- Mohammed V University, Rabat, Morocco
4 Pharmacology and Toxicology group Research-Department of Biology-Faculty of Sciences Ain Chock-UH2-Casablanca, Morocco.
* Corresponding authors: firstname.lastname@example.org@um5.ac.ma
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.
Key words: Quality / Stability / Albendazole tablets / monitoring / impurities
© The Authors, published by EDP Sciences, 2021
This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Current usage metrics show cumulative count of Article Views (full-text article views including HTML views, PDF and ePub downloads, according to the available data) and Abstracts Views on Vision4Press platform.
Data correspond to usage on the plateform after 2015. The current usage metrics is available 48-96 hours after online publication and is updated daily on week days.
Initial download of the metrics may take a while.