Quality of Artesunate Tablets Sold in Pharmacies in Kumasi; Ghana

ABSTRACT

Purpose: The study was carried out to evaluate the quality of artesunate tablets sold in retail and wholesale pharmacies in Kumasi; Ghana. In particular; the study sought to ascertain the presence or otherwise of counter-feit artesunate tablets in Kumasi. Method: Artesunate tablets were purchased from pharmacies in Kumasi for the study. The mechanical properties of the tablets were evaluated; namely uniformity of weight; breaking strength; friability and rate of disintegration in aqueous medium. Colorimetric methods were used to determine the presence of artesunate and to assay the tablets. Result: None of the artesunate tablets sampled was found to be a counterfeit. Most of the brands had acceptable mechanical properties in terms of mass uniformity; hardness; friability and disintegration time. However; the artesunate content of the tablets was variable (47.9-99.9). Six (35.3) of the samples passed the International Pharmacopoeia content uniformity test (93.7-99.9) while 11 (64.7) failed the test (47.9-89.4). However; only 3 (17.6) of the samples met the European Pharmacopoeia (Ph. Eur.) content requirements while 14 (82.4) failed to meet the requirements. Conclusion: The presence of substandard artesunate tablets on the Ghanaian market should alert drug regulatory authorities to be vigilant and continually monitor the quality of this life-saving drug