Comparative Assessment of Different Commercially Available Artemether-Lumefantrine 20/120mg Tablets in Kaduna State, Nigeria.
Keywords:Artemether-Lumefantrine (AL), Tablet, Quality Assessment, Kaduna State
Background: The problems of fake drug proliferation in Nigeria have affected the credibility of the healthcare system and can exert very harmful effects on the consumer resulting to illness, disability and even death which anyone can be a victim. Malaria is a major public health problem in Nigeria and accounts for an estimated 225,000 deaths annually.Artemether-lumefantrine combination remains the first line artemisinin combination therapy (ACT) for treatment of malaria as recommended by World Health Organization (WHO). This study assessed the quality of the various brands of ArtemetherLumefantrine tablets to determine if these products contain the level of active ingredient claimed on the label as well as determine their conformity with specified requirements in the pharmacopoeia. It also determined the percentage content of the various brands using developed HPLC method.
Method: Physical assessment studies, pharmacopoeia test (weight uniformity USP and Dissolution BP) and non-pharmacopeial tests; (hardness, disintegration and friability) were carried, and the percentage content of the active ingredients obtained using developed and validated HPLC method.
Result: The physical assessment tests showed that all artemether-lumefantrine brands conformed to NAFDAC stipulations for packaging and labelling. All the brands passed weight uniformity test, disintegration and friability tests, while 33.4% of the sampled brands failed the hardness test. The result of the dissolution profile for Artemether-Lumefantrine indicated that all samples complied with official standard.Assay of active ingredients using HPLC showed that only 50% ofArtemether sample and 55.6% of Lumefantrine sample met the International Pharmacopoeial7 percentage content requirement of 90% - 110% for bothArtemether and Lumefantrine.
Conclusion: The need to continuously assess the quality of commercially available medicines for use by the populace cannot be overemphasized due to safety reasons.
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