Pharmaceutical equivalent dissertation of Metformin hydrochloride brands

Abstract

The aim of study is to establish pharmaceutical equivalence of different brands of Metformin tablets available in Karachi, Pakistan. The quality control parameters which are studied are weight variation test, hardness test, thickness, friability, disintegration and dissolution specified by BP/USP (British and United State Pharmacopoeia). Weight variation and hardness value requirement was complied by all brands. Disintegration time for all brands was within range i.e. 15 minutes and also complies with the BP/USP recommendation. All brands showed more than 90% drug release within forty five minutes. The present conclusion suggests that almost all the brands of Metformin that are available in Karachi meet the specification for quality control analysis. Assay performed by HPLC by keeping flow rate of 1.0 ml/min of the mobile phase and the quantitative evaluation at 225 nm was performed. The retention time of Metformin was found to be 2.5min. Method suitability for the quantitative determination of the drugs was proved by validation according to the International Conference on Harmonization (ICH) guidelines.