In Vitro Assessment of Quality Control Parameters of Some Commercially Available Generics of Amlodipine Besylate in Nigerian Drug Market

Abstract

Purpose: To use specific parameters to evaluate the in vitro quality assurance of ten generics of amlodipine besylate (10mg) tablets commonly sold in the Nigerian drug market. Methods: Organoleptic and physicochemical properties of 10 brands of the amlodipine besylate tablets were assessed according to official and unofficial standards. Basic quality control parameters evaluated include uniformity of weight, uniformity of content, tablet friability, hardness test, disintegration and dissolution tests. Results: The results show that all the tablets passed the weight uniformity (mean tablet weights ranging from 155±003mg to 404±0.002 mg), friability < 5%, disintegration (< 4 mins) and dissolution tests (>70% released within 40 mins). While seven of the ten brands passed the uniformity of content, two out of the three brands that failed the test were unregistered by NAFDAC. The seven brands can be used interchangeably with the branded, Amlovar®. Conclusion: The finding of this research further underscores the need for stakeholders and end users to insist on the use of only duly registered products by the regulatory body.

Keywords: Amlodipine besylate, control parameters, generics.