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ABSTRACT
The use of artemether-lumenfantrine formulations for the treatment of acute malaria has been on the increase especially in tropical African regions. Hence, there is the need for quality control of these formulations (tablets and susupensions) as several products are introduced into the market annually. Several UV spectrophotometric methods have been developed for analysis of artemether in various formulations, however, the major drawback with these methods is the strenuous heating conditions required for quantification of samples. This poses a limitation in addition with the fact that HPLC is not readily available. In this work, a developed method for assay of artemether-lumenfantrine in susupensions was used and compared with the international pharmacopoeial method for analysis. The developed method involved reacting a solution of artemether in methanol with concentrated HCl for 30 minutes to obtain an alpha, beta unsaturated ketone which was then scanned on a UV spectrophotometer. The developed method was applied in the assay of five brands of artemther-lumenfantrine suspensions using 98-102% drug content as accepted range and comparison of the assay results with the IP 2008 method. The results of the experiment showed that only two brands out of five brands tested, met up to the official limits of drug content(98-102%). This indicates a compliance rate of 40% of artemether-lumefantrine brands in the market, which is a really low percentage and calls for immediate intervention. Hence, there is need for strict quality control of artemether-lumefantrine brands marketed in Nigeria by NAFDAC as there have been reports of many counterfeit products in the market.
