Assessment of the Quality of Antimalarial Medicines Sold in Bukavu, DRC

Abstract

According to 2021 estimates, 247 million people suffered from malaria and 619,000 died from it worldwide. The World Health Organization (WHO) receives reports of substandard or falsified products, of which antimalarials and antibiotics are the most cited. The quality of antimalarial drugs is an important factor contributing to the emergence of resistance in Plasmodium falciparum. This is the reason for this study on the quality control of antimalarial drugs marketed in the Democratic Republic of Congo (DRC) market, in South Kivu/Bukavu. A cross-sectional study was conducted with an analytical aim, which consisted of analyzing the quality of the most consumed antimalarials in Bukavu, including artemether-lumefantrine, sulfadoxine-pyrimethamine, quinine sulfate, and dihydroartemisinin-piperaquine, in tablet form, and quinine bihydrochloride in injectable form. Organoleptic tests, pharmacotechnical tests, and Raman spectroscopy identification were performed on all samples, and quantitative analysis by UV-Visible spectrophotometry and near-infrared spectroscopy in transmission mode was performed. Non-conformity was found during visual examination and pharmacotechnical tests (mass uniformity, friability, and hardness). Lumefantrine, quinine, sulfadoxine, pyrimethamine, dihydroartemisinin, and piperaquine were identified in the samples except artemether, because lumefantrine dominates the Raman spectrum due to the low concentration of artemether in the tablet, according to the method used for identification. For quantification, there was no non-conformity related to the dosage of quinine sulfate and bihydrochloride; however, with regard to artemether-lumefantrine, the lumefantrine concentration was outside the specification for the first five batches, but the sixth batch was conforming according to the specification. It is recommended to enhance packaging and labeling controls to reduce tablet breakage and improve appearance, ensuring compliance prior to market launch. Additionally, refine pharmacotechnical processes.