Volume 1(2), 2021 Hamdard Journal of Pharmacy Vol. 1(2) 2022 ISSN: 2958-5686 24 EVALUATION OF PHARMACEUTICAL EQUIVALENCE OF VARIOUS LOCAL BRANDS OF METFORMIN HCL TABLETS IN PAKISTAN Madiha Arif 1* , Kanwal Hussain 1 , Sohail Hassan 1 1 Department of Pharmaceutical Chemistry, University of Karachi, Karachi, Sindh, Pakistan *Corresponding Author: madihaarif412@gmail.com 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. Keywords: In-Vitro dissolution profile, Metformin, pharmaceutical equivalence INTRODUCTION Metformin HCl belongs to a biguanide class, mainly indicated for type 2 diabetic mellitus. It is an oral anti diabetic drug [1]. Mechanism of action of Metformin is basically to enhance the body sensitivity towards insulin and helps it to consume glucose in a usual way [2]. Moreover, Metformin HCl is a drug of choice for diabetic patients who are overweight or obese, but their renal function also works properly. From research evidence, its use has also been repurposed that Metformin has also been used increasingly for polycystic ovary syndrome [3], a syndrome manifesting hyperandrogenism and ovarian dysfunction [4]. Evidence recommends that Metformin not only acts as insulin sensitizer, but it also recovers hyperandrogenism and shows progress in ovulation and pregnancy rates in patients with PCOS, premature puberty and non- alcoholic fatty liver disease [3]. Those drug products which are equivalent chemically and bio-pharmaceutically must be similar in their purity, strength, quality, and active ingredient release profile so their route Open Access 13-HJPV1(2)-2021 Original Article