Abstract

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