Evaluation of the quality of artemisinin-based antimalarial medicines distributed in Ghana and Togo.
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Date
2014
Journal Title
Journal ISSN
Volume Title
Publisher
Malaria Research and Treatment, Article ID 806416
Abstract
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.
Description
Keywords
Artemisinin-based Combination Therapies, Quality, Substandard, Basic Tests, Semi-quantitative Thin-Layer Chromatography, High Pressure Liquid Chromatography