Pharmaceutical Quality of Antimalarial Drugs: Quinine Sulfate and Artemether/lumefantrine Tablets Sold on Bukavu Market 

Abstract Background: Malaria is a tropical parasitic disease caused by Plasmodium species, mainly falciparum, transmitted by the female Anopheles mosquito, strongly affecting sub-Saharan Africa and Indian areas. Generic antimalarial drugs sold in these regions require tighter quality control as counterfeiting has grown more and more out of control. The study aimed to analyze the pharmaceutical quality of Quinine sulfate and Artemether/Lumefantrine tablets marketed in Bukavu city compared to current trends in other African cities. Methods: We set up 13 simple TLC and UV spectrometric quality-control tests and applied them to analyze five Quinine brands divided into 12 batches and two Artemether/Lumefantrine brands divided into 12 batches. Quality scores were expressed as a percentage of compliance with each or the whole set of 13 tests. The samples were collected from community pharmacies and ambulatory street vendors. For comparison, available literature data related to the subject was retrieved from Google Scholar and PubMed search. Results: The analysis showed 16.6% of QS batches failed quality specifications concerning hardness, friability, and uniformity of mass; 66.6% failed the disintegration test; 33.3% did not contain quinine, and 8.33% had an active ingredient other than quinine. Only 3 batches exhibited a global score >90%. For Artemether/Lumefantrine, 93% of batches had an acceptable quality score >90%. Conclusion: The findings strongly support literature data from many countries. Simple TLC procedures may help to detect any low-quality generics to avoid microbial resistance and guarantee the health of the population. Pharmacists and regulatory authorities are alerted to the circulation of low-quality generic quinine preparations in the country.