Evaluation of the quality of artemisinin-based antimalarial medicines distributed in ghana and togo.
This study, conducted as part of our overall goal of regular pharmacovigilance of antimalarial medicines, reports on the quality of 132 artemisinin-based antimalarial medicines distributed in Ghana and Togo. Three methods were employed in the quality evaluation-basic (colorimetric) tests for establishing the identity of the requisite active pharmaceutical ingredients (APIs), semi-quantitative TLC assay for the identification and estimation of API content, and HPLC assay for a more accurate quantification of API content. From the basic tests, only one sample totally lacked API. The HPLC assay, however, showed that 83.7% of the ACTs and 57.9% of the artemisinin-based monotherapies failed to comply with international pharmacopoeia requirements due to insufficient API content. In most of the ACTs, the artemisinin component was usually the insufficient API. Generally, there was a good correlation between the HPLC and SQ-TLC assays. The overall failure rates for both locally manufactured (77.3%) and imported medicines (77.5%) were comparable. Similarly the unregistered medicines recorded a slightly higher overall failure rate (84.7%) than registered medicines (70.8%). Only two instances of possible cross-border exchange of medicines were observed and there was little difference between the medicine quality of collections from border towns and those from inland parts of both countries.
Department of Chemistry, University of Ghana, Legon, Accra, Ghana.
Dorcas
0000-0001-7311-3485
D
Osei-Safo
Laboratory of Physiology/Pharmacology of Natural Substances, Faculty of Science, University of Lome, Togo.
Amegnona
A
Agbonon
Department of Chemistry, University of Ghana, Legon, Accra, Ghana.
Daniel Yeboah
DY
Konadu
Department of Chemistry, University of Ghana, Legon, Accra, Ghana.
Jerry Joe Ebow Kingsley
0000-0003-2425-3531
JJ
Harrison
Laboratory of Physiology/Pharmacology of Natural Substances, Faculty of Science, University of Lome, Togo.
Mamadou
M
Edoh
Department of Science Laboratory Technology, Accra Polytechnic, Ghana.
Andrew
A
Gordon
Laboratory of Physiology/Pharmacology of Natural Substances, Faculty of Science, University of Lome, Togo.
Messanvi
M
Gbeassor
Department of Chemistry, University of Ghana, Legon, Accra, Ghana.
Ivan
I
Addae-Mensah