EVALUATION OF PHARMACEUTICAL EQUIVALENCE OF VARIOUS LOCAL BRANDS OF METFORMIN HCL TABLETS IN PAKISTAN

13-HJPV2(1)-2021 Original Article

Abstract

Present study aimed to assess pharmaceutical equivalence of five different local brands of Metformin tablets in Pakistan. The brands were treated for different quality attributes according to the BP and USP pharmacopeial and non-pharmacopeial methods. Shelf life was determined by R-Gui software while model independent and dependent approaches were used for in-vitro dissolution profile study. Among all brands, A (2.83) and D (3.5) passed claimed shelf life of 3 years. Moreover, only one out of five brands that is brand A (f2= 53.58 and f1= 5.98) showed equivalence release to innovator (brand C) at each time point in BP mentioned pH 6.8 media, falling in standard range of f2=50-100 and f1=0-15 therefore they are interchangeable (P<0.01). However, the other 3 brands showed insignificant similarity. Present findings supports the need to conduct post-quality evaluation by regulatory authority for locally available pharmaceutical products.