Quality assessment of brands of prednisolone (5 mg) tablets marketed in abuja metropolis of Nigeria

Abstract

This study aims to evaluate the quality of brands of prednisolone tablets marketed in Nigeria. Quality control parameters such as weight variation, hardness, friability, disintegration, assay, and dissolution were assessed. Ten of 11 brands tested met the United States Pharmacopeia (USP) specifications for dissolution of immediate-release dosage forms at stage S1 or S2, but one brand failed to meet the requirement even at stage S3. Using a validated method, all brands except one contained the labelled drug amount per USP specifications (100 ± 10%). Seven brands failed the hardness test, but there were no issues with other parameters like friability, weight variation, and disintegration. This study demonstrates that most generics of prednisolone tablets currently circulating in Abuja, Nigeria are of good quality.