Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia

Abstract

Background 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.

Exploring The Differences : A Comparative Analysis of Pharmaceutical Quality of Different Brands of Metformin Hydrochloride Tablets

“…• Then samples were filtered and the drug content of the sample was determined by measuring the absorbance at maximum at 232 nm. [17,18] ASSAY To quantify medical substances using a spectrophotometer, prepare a solution in a clear solvent and measure its absorbance at an appropriate wavelength. [19] • 20 tablets of Metformin HCl of each brand were weighed and powdered in mortar pestle.…”

“…• Then 10 mL of the resultant solution was further diluted to 100 mL with distilled water to get10 µg/mL [17] • Then absorbance of this solution was measured at maximum at 232nm, and distilled water was used as blank. • According to monograph as A(1%) using the specific absorbance of 798the percentage content of the samples were calculated by using the formula: [20] %𝑀𝑒𝑡𝑓𝑜𝑟𝑚𝑖𝑛 𝐻𝑐𝑙 = 𝐴𝑏𝑠𝑜𝑟𝑏𝑎𝑛𝑐𝑒 𝑜𝑓 𝑠𝑎𝑚𝑝𝑙𝑒 ÷ 𝐴1% × 𝑏 × 𝐷𝑖𝑙𝑢𝑡𝑖𝑜𝑛 𝑓𝑎𝑐𝑡𝑜𝑟(100 ÷ 0.1)[13]…”