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Adane Flatie Alemu,1 Addisu Afrassa Tegegne,2 Nurahmed Seid Getaw1 1Pharmaceutical Analysis, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia; 2Pharmaceutical Quality Assurance and Regulatory Affairs, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, EthiopiaCorrespondence: Addisu Afrassa Tegegne, Email addisuafrassa4648@gmail.comBackground: WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia.Methods: Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability.Results: In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55– 102.76%).Conclusion: The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.Keywords: metformin, quality control, substandard or falsified, Gondar, Ethiopia |
