Validation and application of quality assurance methods developed for artemisinin-based antimalarial drugs to assess the quality of a selection of such drugs distributed in Accra, Ghana
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Date
2010
Journal Title
Journal ISSN
Volume Title
Publisher
Pyramid Pharmaceutical Group Inc., USA Publication
Abstract
A recently developed rapid semi-quantitative Thin Layer Chromatographic (TLC) assay method was applied in the determination of the existence of substandard or counterfeit artemisinin-based antimalarial drugs in the Ghanaian market and also tested for its suitability for rapid assessment of drug quality prior to more rigorous analysis of any suspected counterfeit or substandard drugs. Three methods were employed – Basic Tests, Semi-quantitative TLC assay and High Performance Liquid Chromatographic (HPLC) assay. The basic tests showed that each drug contained the requisite active pharmaceutical ingredient (API). Of the 49 samples (24 single-dose and 25 fixed dose combination formulations) assayed by TLC, only 14 (28.6%) were found to comply with pharmacopoeial specifications. Of the 24 single-dose formulations, 9 of which had been found by the TLC assay to be likely within pharmacopoeial limits, only 4 were eventually found to be fully compliant by HPLC analyses. Two others were marginal. On the basis of the TLC assay, only 5 out of the 25 fixed dose combination formulations that are yet to be accurately assayed by HPLC, appear likely to meet pharmacopoeial specifications. The results of the semi-quantitative TLC technique compare favourably with those of the HPLC and hence can be used for rapid assessment of the quality of antimalarial drugs. The results also indicate that the problem of distribution of substandard and possibly counterfeit artemisinin-based antimalarial drugs exists in Ghana.
Description
Keywords
Artemisinin, antimalarial drugs, quality assurance, semi-quantitative Thin Layer Chromatography, High Pressure Liquid Chromatography
Citation
African Journal of Pharmaceutical Sciences and Pharmacy, 1:1, 1-26.