Comparative quality control studies on three brands of metformin hydrochloride tablets marketed in Kaduna, Nigeria

Abstract

The introduction of generic drug products from multiple sources into the health care delivery system of many developing countries is aimed at improving the overall health delivery systems in such countries. However, this has been accompanied by a variety of problems of which the most critical is the widespread distribution of fake and substandard drug products. The study aimed at comparative quality control studies on metformin hydrochloride tablets (500 mg) marketed in Kaduna areas. Three brands of metformin tablets (500 mg) were selected and evaluated comparatively for their physical and chemical parameters using standard methods. The physicochemical equivalences of all the tablet brands were assessed through evaluation of both official and non-official standards such as uniformity of weight, friability, hardness, disintegration, assay and dissolution rate. Disintegration time for all brands was within 15 minutes prescribed by official compendia. All brands of metformin hydrochloride tablets fulfilled the official in-vitro dissolution rate test specification as more than 70% of the drugs were released within 45 minutes. The present findings suggest that the three brands of metformin hydrochloride, available in Kaduna, conformed with the I.P. specifications for quality control analysis and are thus interchangeable.

Keywords: Metformin hydrochloride, Counterfeit; in-vitro; tablet properties, quality control

Journal of Pharmaceutical and Allied Sciences, Vol. 16 No.4 (2019)