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CHARACTERIZATION OF COUNTERFEIT ARTESUNATE ANTIMALARIAL TABLETS FROM SOUTHEAST ASIA

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  • 1 School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford, United Kingdom; Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Laboratory of Analytical Chemistry, Ghent University, Ghent, Belgium; Light Impressions International, Leatherhead, Surrey, United Kingdom; Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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In southeast Asia, the widespread high prevalence of counterfeits tablets of the vital antimalarial artesunate is of great public health concern. To assess the seriousness of this problem, we quantified the amount of active ingredient present in artesunate tablets by liquid chromatography coupled to mass spectrometry. This method, in conjunction with analysis of the packaging, classified tablets as genuine, substandard, or fake and validated results of the colorimetric Fast Red TR test. Eight (35%) of 23 fake artesunate samples contained the wrong active ingredients, which were identified as different erythromycins and paracetamol. Raman spectroscopy identified calcium carbonate as an excipient in 9 (39%) of 23 fake samples. Multivariate unsupervised pattern recognition results indicated two major clusters of artesunate counterfeits, those with counterfeit foil stickers and containing calcium carbonate, erythromycin, and paracetamol, and those with counterfeit holograms and containing starch but without evidence of erythromycin or paracetamol.

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