In vitro dissolution studies and pharmaceutical equivalence assessment of metformin hydrochloride tablets commercially available in Salvador, Bahia, Brazil
International Journal of Development Research
In vitro dissolution studies and pharmaceutical equivalence assessment of metformin hydrochloride tablets commercially available in Salvador, Bahia, Brazil
Received 08th December, 2019; Received in revised form 24th January, 2020; Accepted 04th February, 2020; Published online 31st March, 2020
Copyright © 2020, Gilmar Antôniode Carvalho Teles Júnior et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
