Publications

Metformin is an anti-diabetic drug classified as a biguanide used as the first-line drug of choice for the treatment oftype-2 diabetes particularly in overweight and obese patients and those with normal kidney function. The aim ofthis study was to investigate the quality of metformin brands sold in Ishaka-Bushenyi. Four brands were randomlyselected and purchased from pharmacies in Ishaka. The brands were assessed for weight variation, friability,hardness, disintegration, dissolution, and assay using a UV spectrophotometer. 20 tablets were used for the weightvariation test, 10 were used for hardness from each brand, 10 tablets were used for friability, 6 tablets fordisintegration, 6 tablets for dissolution, and 10 tablets for UV assay from each brand. All the brands tested for weightwere within the official specifications of ±7.5% deviation and the percentage weight loss values for all four brandsA, B, C, and D are well within the USP limit with the highest percentage weight loss being 0.47%. Brands A, B, andC passed the hardness test having a crushing strength of more than 4kg/cm2 while brand D failed having a crushingstrength of 2.72kg/cm2. All four brands have disintegration times with mean values ranging from 5.5 to 13.167minutes hence passing this test. The BP specification for dissolution testing of metformin hydrochloride tablets 500mg requires that at least 75% of the API is released within 45 minutes. All four brands pass this test as theirpercentage release is above 75% at 30 minutes. Brand A, B, and C fall within the USP specification range for assaywith mean percentage concentrations of 99.81%, 99.56%, and 99.56% respectively. Brand D falls well outside therange, with a mean percentage concentration of 92.08% which is below the USP specifications of 95% to 105%.Metformin tablets sold in Ishaka pass the quality tests and have minimal variations among brands. These resultshighlight the importance of the need for regular quality tests on brands of metformin on the market.