Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana

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 counterfeit 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. Keywords: Artesunate tablets, Artemisinins, Fast-red TR salt, Counterfeit drugs, Substandard drugs.Tropical Journal of Pharmaceutical Research Vol. 7(4) 2008: pp. 1179-118