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. 400 ALsamples were collected from the different Pharmacies in the different cities and the corresponding LTRs in thestrengths of 20/120, 60/360 and 80/480 with commonest brands Lumartem, Lumaren and Artefan. The presenceof A/L brands that are unregistered and the total assay failure of the brands of 18% for the AL tablets purchasedcauses alarm.Keywords: Artemether lumefantrine, quality, tablets, prevalence