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.
Highlights
In developing countries, where antihelminthic drugs are mostly imported or manufactured locally as low cost generics, risks are high regarding the quality of these drugs, as they could be impacted in terms of the content of the active ingredient, as well as their purity, dissolution and bioavailability, impacting their therapeutic effectiveness [1]
It was quantified by liquid chromatography – Ultra Violet (UV) detector [6, 7], Reversed-Phase High Performance Liquid
In order to find more accurate and easy methods to control the quality of the marketed drugs, this study aimed to develop and validate an RP-HPLC stability indicating method for the simultaneous analysis of Albendazole tablets (Alb) dosage as an active pharmaceutical ingredient and Imp B and Imp C as related substances within normal conditions
Summary
In developing countries, where antihelminthic drugs are mostly imported or manufactured locally as low cost generics, risks are high regarding the quality of these drugs, as they could be impacted in terms of the content of the active ingredient, as well as their purity, dissolution and bioavailability, impacting their therapeutic effectiveness [1]. Albendazole is widely used thanks to its broad activity spectrum To be efficient, it should have the required physical and chemical qualities. The pharmaceutical form of Alb has been evaluated by several quality assessment techniques. It was quantified by liquid chromatography – Ultra Violet (UV) detector [6, 7], Reversed-Phase High Performance Liquid. In order to find more accurate and easy methods to control the quality of the marketed drugs, this study aimed to develop and validate an RP-HPLC stability indicating method for the simultaneous analysis of Alb dosage as an active pharmaceutical ingredient and Imp B and Imp C as related substances within normal conditions. The quality evaluation of Alb original and generic tablets marketed in Africa was studied
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