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Background Generic antimalarial drugs sold in sub-Saharan Africa require tighter control as counterfeiting has grown more and more out of control. The study aimed to analyze the pharmaceutical quality of quinine sulfate (QS) and Artemether/Lumefantrine(AL) tablets marketed in Bukavu city compared to the current trends in other African cities. Results The samples were purchased in community pharmacies or from ambulatory street vendors and analyzed using a set of thirteen simple tests, including visual inspection, UV spectrometry, TLC, and conventional quality control procedures. More than 93% of AL samples had an acceptable global quality score of > 90%. Around 16.6% of QS batches did not satisfy the requirements about hardness, friability, and mass uniformity. Only 33.3% met the disintegration quality; 33.3% did not contain quinine; 8.33% had an active ingredient other than quinine. Conclusion The findings strongly alert the circulation of fake antimalarial medicines observed in 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.

The development of the spectrofluorimetric method can be considered a promising alternative that is relatively less expensive and sufficiently reliable. In the current literature, no method for the analysis of nevirapine by spectrofluorimetric has been reported. The proposed method is based on the transformation of naturally non-fluorescent nevirapine into a fluorescent derivative after chemical synthesis. Maximum excitation and emission wavelengths are 290 nm and 357 nm respectively. The analytical performance of the method demonstrates linearity in the concentration range 1.5 × 10 −2 and 13.5 × 10 −2 μg/mL with a correlation coefficient (r) greater than 0.999. The detection (LOD) and quantification (LOQ) limits found are 1.97 × 10 −3 μg/mL and 5.48 × 10 −3 μg/mL respectively. Recovery is achieved with 99.9% and 100.3% trueness, intra-day precision with a coefficient of variation of repeatability (CVr) of 0.99% and inter-day precision with a coefficient of variation of precision (CVR) of 1.7%. The method has been successfully applied in the analysis of 10 batches of nevirapine tablets and suspensions.

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.