• 1.

    WHO, 2012. Factsheet on the World Malaria Report 2012. Available at: http://www.who.int/malaria/media/world_malaria_report_2012_facts/en/. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 2.

    WHO, 2012. World Malaria Report 2012. Available at: http://www.who.int/malaria/publications/world_malaria_report_2012/en/index.html. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 3.

    Cesar ID, Nogueira FHA, Pianetti GA, 2008. Simultaneous determination of artemether and lumefantrine in fixed dose combination tablets by HPLC with UV detection. J Pharm Biomed Anal 48: 951954.

    • Search Google Scholar
    • Export Citation
  • 4.

    WHO, 2000. WHO Expert Committee on Malaria: Twentieth Report. WHO Technical Report Series 892. Available at: http://apps.who.int/iris/bitstream/10665/42247/1/WHO_TRS_892.pdf. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 5.

    WHO, 2006. Counterfeit Medicines: The Silent Epidemic. Available at: http://www.who.int/mediacentre/news/releases/2006/pr09/en/. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 6.

    Nayyar GML, Breman JG, Newton PN, Herrington J, 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.

    • Search Google Scholar
    • Export Citation
  • 7.

    WHO, 2001. Antimalarial Drug Combination Therapy. Report of a WHO Technical Consultation, April 4–5, 2001. Available at: http://apps.who.int/iris/bitstream/10665/66952/1/WHO_CDS_RBM_2001.35.pdf. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 8.

    Green MD, Mount DL, Wirtz RA, 2001. Authentication of artemether, artesunate and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop Med Int Health 6: 980982.

    • Search Google Scholar
    • Export Citation
  • 9.

    Atemnkeng MA, De Cock K, Plaizier-Vercammen J, 2007. Quality control of active ingredients in artemisinin-derivative antimalarials within Kenya and DR Congo. Trop Med Int Health 12: 6874.

    • Search Google Scholar
    • Export Citation
  • 10.

    Arun R, Smith AA, 2011. Simultaneous HPLC-UV method for the estimation of artemether and lumefantrine in tablet dosage form. Int J Pharm Biomed Res 2: 201205.

    • Search Google Scholar
    • Export Citation
  • 11.

    Ezzet F, van Vugt M, Nosten F, Looareesuwan S, White NJ, 2000. Pharmacokinetics and pharmacodynamics of lumefantrine (benflumetol) in acute falciparum malaria. Antimicrob Agents Chemother 44: 697704.

    • Search Google Scholar
    • Export Citation
  • 12.

    Hodel EM, Zanolari B, Mercier T, Biollaz J, Keiser J, Olliaro P, Genton B, Decosterd LA, 2009. A single LC-tandem mass spectrometry method for the simultaneous determination of 14 antimalarial drugs and their metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 877: 867886.

    • Search Google Scholar
    • Export Citation
  • 13.

    Cesar IC, de Aquino Ribeiro JA, de Souza Teixeira L, Bellorio KB, de Abreu FC, Moreira JM, Chellini PR, Pianetti GA, 2011. Liquid chromatography-tandem mass spectrometry for the simultaneous quantitation of artemether and lumefantrine in human plasma: application for a pharmacokinetic study. J Pharm Biomed Anal 54: 114120.

    • Search Google Scholar
    • Export Citation
  • 14.

    WHO, 2003. Substandard and Counterfeit Medicines. Geneva, Switzerland: World Health Organization.

  • 15.

    Newton PN, Green MD, Fernández FM, Day NP, White NJ, 2006. Counterfeit anti-infective drugs. Lancet Infect Dis 6: 602613.

  • 16.

    Bate R, Coticelli P, Tren R, Attaran A, 2008. Antimalarial drug quality in the most severely malarious parts of Africa: a six country study. PLoS One 3: e2132.

    • Search Google Scholar
    • Export Citation
  • 17.

    Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NP, Greenwood BM, Nosten F, White NJ, 2006. Manslaughter by fake artesunate in Asia: will Africa be next? PLoS Med 3: e197.

    • Search Google Scholar
    • Export Citation
  • 18.

    Ofori-Kwakye K, Asantewaa Y, Gaye O, 2008. Quality of artesunate tablets sold in pharmacies in Kumasi, Ghana. Trop J Pharm Res 7: 11791184.

  • 19.

    Yamey G, Schäferhoff M, Montagu D, 2012. Piloting the Affordable Medicines Facility-Malaria: What Will Success Look Like? Bulletin of the World Health Organization. Available at: http://www.who.int/bulletin/volumes/90/6/11-093849/en/. Accessed November 15, 2013.

    • Search Google Scholar
    • Export Citation
  • 20.

    WHO, 2014. Malaria: High-Risk Groups. Available at: http://www.who.int/malaria/areas/high_risk_groups/en/. Accessed November 5, 2014.

  • 21.

    Moormann AM, 2009. How might infant and paediatric immune responses influence malaria vaccine efficacy? Parasite Immunol 31: 547559.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 

 

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

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  • 1 Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana.
  • | 2 Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
  • | 3 School of Allied Health Sciences, University of Ghana, Korle-Bu, Ghana.
  • | 4 Department of Pharmacognosy and Herbal Medicine, School of Pharmacy, University of Ghana, Legon, Ghana.
  • | 5 Department of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, Legon, Ghana.
  • | 6 Laboratory Services Department, Food and Drugs Authority, Cantonments, Ghana.
  • | 7 Department of Animal Experimentation, Noguchi Memorial Institute for Medical Research, Legon, Ghana.
  • | 8 Department of Infectious Diseases, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
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We developed and validated a new analytical method for the simultaneous quantification of artemether and lumefantrine in fixed-dose tablets and powders for reconstitution into pediatric suspensions (PSs). The method showed linearity (r2 > 0.9947), precision (coefficient of variation < 2%), accuracy (deviation of mean from actual concentrations < 4%), and specificity (peak purities > 99%). The validated method was used to analyze 24 batches of fixed-dose tablets and PSs of artemether and lumefantrine. Of the samples, 23 were obtained using convenience sampling of commonly available brands within Accra in Ghana and one was obtained from Aarhus University Hospital. In all, 83.3% (confidence interval: 80–120%) passed for both artemether and lumefantrine contents, 16.7% failed by the U.S. Pharmacopoeia standards, 8.3% failed for one content, and 8.3% failed for both contents. All four products (16.7%) that failed were PSs, and two (8.3%) showed higher levels of artemether than prescribed (222% and 756%).

Author Notes

* Address correspondence to Philip Debrah, Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, P.O. Box LG43, Legon, Accra, Ghana. E-mail: pdebrah@ug.edu.gh

Authors' addresses: Philip Debrah and Henry Nettey, Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana, E-mails: pdebrah@ug.edu.gh and hnettey@ug.edu.gh. Katja Kjeldgaard Miltersen, Birgitte Brock, and Tore Forsingdal Hardlei, Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark, E-mails: qatja@hotmail.com, birgitte.brock@skejby.rm.dk, and torehard@rm.dk. Patrick Ayeh-Kumi, School of Biomedical and Allied Health Sciences, University of Ghana, Korle-Bu, Ghana, E-mail: payehkumi@yahoo.com. Joseph Adusei Sarkodie, Department of Pharmacognosy and Herbal Medicine, School of Pharmacy, University of Ghana, Legon, Ghana, E-mail: jsarkodie@ug.edu.gh. Irene Akwo-Kretchy, Department of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, Legon, Ghana, E-mail: iakretchy@yahoo.com. Patrick Owusu-Danso, Laboratory Services Department, Food and Drugs Authority, Cantonments, Ghana, E-mail: patrickowusudanso@yahoo.com. Samuel Adjei, Department of Animal Experimentation, Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana, E-mail: sadjei@noguchi.ug.edu.gh. Eskild Petersen, Department of Infectious Diseases, Aarhus University Hospital, Skejby, Denmark, E-mail: joepeter@rm.dk.

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