Determination of Concentration of Active Pharmaceutical Ingredients in Different Brands of Artemether/Lumefantrine Tablets Sold in the Pharmacies in Uganda
Buyinza Nicholas, Jonans Tusiimiire and Silvano Twinomujuni
Department of Pharmaceutics & Pharmaceutical Technology, Kampala International University, Uganda
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
CITE AS: Buyinza Nicholas, Jonans Tusiimiire and Silvano Twinomujuni (2024). Determination of Concentration of Active Pharmaceutical Ingredients in Different Brands of Artemether/Lumefantrine Tablets Sold in the Pharmacies in Uganda. IDOSR JOURNAL OF SCIENTIFIC RESEARCH 9(1) 43-50. https://doi.org/10.59298/IDOSRJSR/2024/1.1.4342.100