Abstract:

Introduction: The assessment of physical and chemical quality parameters of a pharmaceutical product using internationally recognized pharmacopoeia is crucial in assuring that only products of acceptable quality circulate in the market. The use of substandard and counterfeit medicinal products has been associated with treatment failure, development of disease causative agent resistance against the drug, adverse drug reactions and sometimes death. Therefore this study aimed to assess physical and chemical parameters of four Albendazole tablets brands as per United States Pharmacopeia (USP 38 NF 33) monographs. The investigated parameters include hardness, mass uniformity for physical and amount of active pharmaceutical ingredient (API), dissolution for chemical parameters. These assessed brands included Alben® (Shelys, Tanzania), Finazol® (Fourrts, India), Zentel® (GSK, South Africa) and Alzental® (Shin Poong, South Korea) which were collected from pharmacies in Mwanza city.

Methods: All samples were prepared according to the standard operating procedures (SOPs) and necessary calculations were made. Then all procedures were done using specified equipment and material, data was then collected and analyzed.

Results: Among the four parameters investigated, only two parameters (mass uniformity and amount of active pharmaceutical ingredient) complied with the USP specifications for all four brands while for the other two (hardness and dissolution) did not comply. Although only one brand. Zentel® complied with the dissolution test.

Conclusion: Therefore the periodic monitoring programs of marketing authorized products are important to ensure the quality of circulating medicine in the market.