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CHARACTERIZATION OF COUNTERFEIT ARTESUNATE ANTIMALARIAL TABLETS FROM SOUTHEAST ASIA

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.

Received March 4, 2006. Accepted for publication June 11, 2006.

Acknowledgments: We are extremely grateful to Professors Nicholas White and Nicholas Day and all who assisted in the collection of samples.

Financial support: Analysis of antimalarial drug samples was supported by a starter grant from the Society of Analytical Chemists of Pittsburgh (United States) to Facundo M. Fernandez. Collection of artesunate samples was supported by the Wellcome Trust of Great Britain as part of the Wellcome Trust-South East Asian Oxford Tropical Medicine Research Collaborations.

^* Address correspondence to Facundo M. Fernandez, School of Chemistry and Biochemistry, Georgia Institute of Technology, 770 State Street, Atlanta, GA 30332. E-mail: facundo.fernandez{at}chemistry.gatech.edu

Authors’ addresses: Krystyn Alter Hall and Facundo M. Fernandez, School of Chemistry and Biochemistry, Georgia Institute of Technology, 770 State Street, Atlanta, GA 30332, Telephone: 404-385-4432, Fax: 404-385-6447, E-mails: krystyn.hall{at}gmail.com and facundo.fernandez{at}chemistry.gatech.edu. Paul N. Newton, Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR and Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom. Michael D. Green, Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop F12, Atlanta, GA 30333, E-mail: mdg4{at}cdc.gov. Marleen de Veij and Peter Vandenabeele, Laboratory of Analytical Chemistry, Ghent University, Proeftuinstraat 86, B-9000 Ghent, Belgium, E-mail: peter.vandenabeele{at}UGent.be. David Pizzanelli, Light Impressions International, 5 Mole Business Park 3, Randalls Road, Leatherhead, Surrey KT22 7BA, United Kingdom, E-mail: david{at}pizzanelli.wanadoo.co.uk. Mayfong Mayxay, Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR, and Department of Post Graduates and Research, Faculty of Medical Science, National University of Laos, Lao PDR. Arjen Dondorp, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford University, Oxford OX3 7LJ, United Kingdom and Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok, 10400, Thailand, E-mail: arjen{at}tropmedres.ac.

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