Assessment of the quality and dissolution profiles of branded fixed dose artemether/ lumefantrine tablets sold at pharmacies in Kampala- Uganda

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Kampala International University, School of Health Sciences- Western Campus
This study was done to evaluate the physicochemical properties, quality control parameters and the dissolution profiles of circulating samples of artemether/lumefantrine sold at Pharmacies in Kampala. The physicochemical parameters and assay of thirteen ( 13) brands of the products were assessed through the evaluation of uniformity of tablet weight, friability test, disintegration test and assay of active pharmaceutical ingredients according to established methods. The dissolution rate was determined according to the USP SALMOUS Standard. All brands complied with official requirements for uniformity of weight and friability. The disintegration time had higher time in artificial gastric medium relative to distilled water. Evaluation of content of active ingredients revealed that 38.5 percent of tested samples were failing test for assay. With the exception of three brands, all the brands complied with the requirements for dissolution test. Overall, 54 percent of the brands conformed to all the compendia specifications and 46 percent were substandard. Future studies should test for a greater number of samples per batch, aim at comparing dissolution profile in various biological medium and investigate reasons for poor dissolution performance of some brands.
A research dissertation submitted To Kampala International University School of pharmacy in part al fulfillment of the requirement of a ward of Bachelor of pharmacy Degree
Quality Profiles, Dissolution profiles, Branded fixed dose artemether/ lumefantrine tablets, Uganda