Publications

Substandard, counterfeit and falsified antimalarial agents are a big challenge to effective malaria eliminationinterventions mainly in developing countries. In low-and middle-income countries (LMICs), the quality ofantimalarial agents inclusive of AL is affected by several factors including insufficient regulation porous borders andlimited funds. This study therefore focused evaluation of quality of different brands of fixed dose artemether/lumefantrine tablets sold in Ugandan Pharmacies. This was an experimental study conducted using AL tabletsobtained from different pharmacies in the different cities of Uganda purchased using mystery shopper method. Thesamples were screened for quality using visual inspection, assessed different physical quality parameters like weightvariation, friability, disintegration and dissolution and content assay tests were also done both for the brands fromthe pharmacies and their correspondent LTR. The assay test was done using HPLC technique USP method. Thesamples were considered substandard if the API content was outside 90-110% range of the label claim. Data wasanalysed using descriptive statistics and presented as means with standard deviations and frequencies. Out of the 16brands in the study, 14 brands (88%) passed the artemether assay and two brands failed at 89.8% and 110.2% ofdeclared artemether content. For Lumefantrine assay, out of the 16 brands in the study, 14 brands (88%) passed theLumefantrine assay except two brands (12%). The presence of A/L brands that are unregistered and the total assayfailure of the brands of 18% for the AL tablets purchased causes alarm and the total assay failure of the brands of18% for the AL tablets purchased calls for NDA to intensify on its operations to find out the conformity of thepharmacies to selling only registered medicines.Keywords: Artemether Lumefantrine, Quality, Tablets