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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dc.contributor.author Osei-Safo, D.
dc.contributor.author Harrison, J.J.E.K.
dc.contributor.author Addae-Mensah, I.
dc.date.accessioned 2013-01-04T09:59:15Z
dc.date.accessioned 2017-10-14T12:13:15Z
dc.date.available 2013-01-04T09:59:15Z
dc.date.available 2017-10-14T12:13:15Z
dc.date.issued 2010
dc.identifier.citation African Journal of Pharmaceutical Sciences and Pharmacy, 1:1, 1-26. en_US
dc.identifier.uri http://197.255.68.203/handle/123456789/2453
dc.description.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. en_US
dc.language.iso en en_US
dc.publisher Pyramid Pharmaceutical Group Inc., USA Publication en_US
dc.subject Artemisinin en_US
dc.subject antimalarial drugs en_US
dc.subject quality assurance en_US
dc.subject semi-quantitative Thin Layer Chromatography en_US
dc.subject High Pressure Liquid Chromatography en_US
dc.title 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 en_US
dc.type Article en_US


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