Quality survey of some brands of artesunate- amodiaquine in Lagos drug market

With the advent of Artemisinin Combination Therapy (ACTs) as the recommended treatment protocol for malaria by WHO, the menace of substandard and counterfeit anti-malaria drugs have been on the rise. Artesunate-amodiaquine, like other ACTs, has been widely implicated in this menace due to the market value and affordability. 13 representative brands of Artesunate/Amodiaquine were procured from different outlets in urban and peri-urban parts of Lagos, Nigeria. Quantitative and qualitative analysis were carried out on the different brands using HPLC. The results show all brands to contain the test APIs but in proportions varied about the USP specified limits. 30.8% of the test brands had artesunate within the USP specification. 30.8% of amodiaquine also had met the quality specification of USP. But only 15.4% of the sample had both amodiaquine and artesunate within the USP specification. 53.8% failed the active content test for both amodiaquine and artesunate.

[1]  Go Adewuyi,et al.  Development and validation of a thin layer chromatographic method for the determination of artesunate and amodiaquine in tablet formulations , 2011 .

[2]  Kamolrat Silamut,et al.  Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial , 2010, The Lancet.

[3]  S. Gandhi,et al.  A simple and sensitive RP-HPLC method for simultaneous estimation of Artesunate and Amodiaquine in combined tablet dosage form. , 2010 .

[4]  Roger Bate,et al.  Pilot Study Comparing Technologies to Test for Substandard Drugs in Field Settings , 2009 .

[5]  A. Attaran,et al.  Antimalarial Drug Quality in the Most Severely Malarious Parts of Africa – A Six Country Study , 2008, PloS one.

[6]  G. Kokwaro,et al.  Antimalarial drug quality in Africa , 2007, Journal of clinical pharmacy and therapeutics.

[7]  M. Green.  Antimalarial drug resistance and the importance of drug quality monitoring. , 2006, Journal of Postgraduate Medicine.

[8]  Paul N Newton,et al.  Counterfeit anti-infective drugs. , 2006, The Lancet. Infectious diseases.

[9]  M. Mota,et al.  Antimalarial drugs – host targets (re)visited , 2006, Biotechnology journal.

[10]  S. Krishna,et al.  Artemisinins: mechanisms of action and potential for resistance. , 2004, Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy.

[11]  D. Conway,et al.  A large focus of naturally acquired Plasmodium knowlesi infections in human beings , 2004, The Lancet.

[12]  C. D. Fitch.  Ferriprotoporphyrin IX, phospholipids, and the antimalarial actions of quinoline drugs. , 2004, Life sciences.

[13]  S. Hoffman,et al.  Primaquine for prevention of malaria in travelers. , 2003, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[14]  G. Tomson,et al.  Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar Es Salaam Tanzania , 2003, Journal of clinical pharmacy and therapeutics.

[15]  T. Wellems.  Plasmodium Chloroquine Resistance and the Search for a Replacement Antimalarial Drug , 2002, Science.

[16]  B. Greenwood,et al.  Malaria in 2002 , 2002, Nature.

[17]  C. Herforth.  Antimalarial Activity of , 2002 .

[18]  M. Foley,et al.  Quinoline antimalarials: mechanisms of action and resistance and prospects for new agents. , 1998, Pharmacology & therapeutics.

[19]  M. Foley,et al.  Quinoline antimalarials: mechanisms of action and resistance. , 1997, International journal for parasitology.

[20]  J. Cumming,et al.  Antimalarial activity of artemisinin (qinghaosu) and related trioxanes: mechanism(s) of action. , 1997, Advances in pharmacology.