A Comparative In-Vitro study for Evaluation of different Marketed brands of Metformin Hydrochloride (500 mg) Tablets
Keywords:
Metformin hydrochloride, In–vitro study, Physicochemical equivalency, Dissolution rate, Comparative evaluationAbstract
Metformin hydrochloride is an first line anti-diabetic drug used for the
treatment of type II diabetes mellitus especially in obese patients.
Various brands of metformin are available in the market which makes it
challenging to select, effective and economic one. The aim of the present
research work was designed to examine, compare and evaluate the
different marketed brands of metformin tablets for their performance.
Four brands of metformin tablets (500 mg) were selected and evaluated
comparatively for their physical and chemical parameters as per official
method. The physicochemical equivalence of all brands of metformin
hydrochloride tablets were determined through the evaluation of official
standards according to the USP, IP including uniformity of weight,
friability, hardness, disintegration time, dissolution profile and drug
content. Weight variation and friability test of all brands was within the
specified limit.
Disintegration time for all brands was within 15 minutes prescribed by official compendium. All the four
brands of Metformin hydrochloride tablets fulfilled the official in – vitro dissolution rate test specification
more than 80 % of the drug is released within 30 minutes. UV analysis of different sample shows that the
percentage content of active ingredients of four brands of metformin hydrochloride tablets was within the
monograph specification (95 – 105 %). All the four brands of metformin hydrochloride tablets taken for
comparative evaluation gives different result from each other but meet the pharmacopoeial specification
for quality control analysis. The result indicated that all the selected brand fulfilled the required official
specification and thus if one brand is not available in the marketthenany of the other brands can be used
freely as a substitute of that unavailable brand.
