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: hssaineamine@gmail.combrahim.benaji@um5.ac.ma

Abstract

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.