African Journal of Pharmacy and Pharmacology Vol. 6(9), pp. 636-642, 8 March, 2012 Available online at http://www.academicjournals.org/AJPP DOI: 10.5897/AJPP11.841 ISSN 1996-0816 ©2012 Academic Journals Full Length Research Paper Quality survey of some brands of artesunate- amodiaquine in Lagos drug market Teddy Ehianeta, Bidemi Williams, Jadesola Surakat, Nura Mohammed and Chimezie Anyakora* Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria. Accepted 8 February, 2012 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. Key words: Artemisinin combination therapy (ACTs), WHO, malaria, high-performance liquid chromatography (HPLC). INTRODUCTION Statistics have shown that malaria is the fifth leading cause of death worldwide, with 3.3 billion people at risk (World malaria report, 2010). Several centuries after its discovery, malaria remains a devastating human infection, totaling 300 to 500 million clinical cases and three million deaths every year (World Malaria Report, 2010), but many of these death would be avoided if anti- malaria drugs were effective (Bate et al., 2009). Since 2001, the World Health Organization has recommended that malaria-endemic African countries should consider changing to artemisinin derivative- based combination therapy (ACT) as first-line malaria treatment. Malaria is presently endemic in a broad band around the equator, in areas of the Americas, many parts of Asia, and much of Africa; however, it is in sub-Saharan Africa where 85 to 90% of malaria fatalities occur (Layne, 2006). The geographic distribution of malaria within large regions is complex, and malaria-afflicted and malaria-free areas are often found close to each other (Greenwood et al., 2002). *Corresponding author. E-mail: canyakora@gmail.com. ACTs have been largely successful in combating malarial in Africa. Successful drugs such as ACTs are at risk of being counterfeited or produced with insufficient quality control resulting in substandard products. Since more than 40% of the world's population is at risk of malaria, antimalarial drugs have become a favorite target of counterfeiters. For instance, counterfeit artemisinins are a significant problem in Southeast Asia (Singh, 2004) and are expected to become a serious problem in Africa where artemisinin combination therapy is being implemented (Dondorp et al., 2010). It has been estimated that the counterfeit medicine market is worth some US$ 35 to 44 billion per year (Newton et al., 2006). Hence, the need for an effective post-marketing surveillance of all medications especially those used in treating priority disease. Post Marketing Surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. These substandard products contain active pharma- ceutical ingredients below or above the range recom- mended by the USP. A lower dose than the labeled dose of the active medicament leads to a delivery of lower concentration to the blood plasma. This consequently