Quality control of active ingredients in artemisinin-derivative antimalarials within Kenya and DR Congo.

OBJECTIVES: Artemisinin-derivative drugs are widely used to treat Plasmodium falciparum malaria and very few studies have investigated the quality of these medicines in Africa. We analysed the active ingredient contents of artemisinin-derivative drugs marketed in Kenya and DR Congo. METHODS: We analysed tablets, capsules, dry suspensions and injections (IM) containing either artemether (AM), arteether (AE), artesunate (ARS) or dihydroartemisinin (DHA). The content of active ingredients and preservatives was determined quantitatively using validated HPLC-UV methods. All analyses were done according to European pharmacopoeia requirements. RESULTS: Labelled active ingredients were identified in all samples, however with varying dosages. Nine of the 24 drug samples analysed did not comply with the pharmacopoeial requirements of 95-105%: seven samples were underdosed and two were slightly overdosed. DHA was the active ingredient in 57% of the underdosed samples. AE injections had the lowest drug content (77%). Two-thirds of the dry powder suspensions were either substandard or fake. Tablets were up to 23% out of range. Unidentified peaks were observed on the chromatograms of AE IM injections and a DHA dry powder. CONCLUSIONS: Counterfeit or substandard artemisinin-derivative drugs are being sold in parts of Africa, presenting a potential route for resistance development in the future. Appropriate measures need to be taken to maintain proper and safe use of these medicines.