In vitro dissolution studies and pharmaceutical equivalence assessment of metformin hydrochloride tablets commercially available in Salvador, Bahia, Brazil

International Journal of Development Research

Volume: 
10
Article ID: 
18568
5 pages
Research Article

In vitro dissolution studies and pharmaceutical equivalence assessment of metformin hydrochloride tablets commercially available in Salvador, Bahia, Brazil

Gilmar Antôniode Carvalho Teles Júnior, Fernanda de Souza Dias, Matheus da Silva Ferreira, Anderson Silva de Oliveira, Vagner Cardoso da Silva and Aníbal de Freitas Santos Júnior

Abstract: 

Metformin is a drug widely used in worldwide for type 2 diabetes mellitus treatment. The aim of this study was to compare the dissolution profiles of Metforminhydrocloride tablets (850 mg) available as the reference drug (R), generic (G) and similar (S) commercialized in Bahia, Brazil using a simple, fast and low cost ultraviolet spectrophotometric method. The tests were performed in compliance with the Brazilian Pharmacopoeia and United States Pharmacopeias. The proposed methodology for quantifying the drug was validated presenting precision, linearity and accuracy. All the products released metformin satisfactorily (>75% of the drug dissolved within 45 min). The product R, G and S showed dissolution efficiency of 83.85, 76.67 and 75.04%, respectively. From the calculation of similarity factor (f2), the formulations were considered pharmaceutical equivalents.

Download PDF: