Comparative evaluation of prednisolone 5MG tablets marketed in Bangladesh

Abstract

The aim of the present study is to determine the quality and to correlate with other different brands of pharmaceutical products marketed in Bangladesh for the healthcare of patients suffering from different respiratory inflammation like asthma, and auto-immune disorders. The experiment is done to evaluate and compare the physicochemical equivalence of different brands of Prednisolone 5mg tablet. These tablets were tested through statistical methods in accordance with the BP and USP like weight variation, thickness, hardness, friability, disintegration, in-vitro dissolution and HPLC assay. The in vitro dissolution studies of Prednisolone 5 mg tablets were carried out in pH 7 distilled water for 30 minutes using USP-II method whose absorbance were taken at 246 nm using UV spectrophotometry. Six samples showed poor in-vitrodissolution whichwere non-equivalent to the USP monograph specification giving Prednisolone content less than 75%. The percentage content of active ingredient of different brands were tested using HPLC assay. Samples showed values within the specifications (90-110%) except some of the companies. Two samples did not undergo disintegration at all when given in the disintegration tester. However, no major problem was found in others physical parameters like tablet weight variation, thickness, hardness and friability. Finally from the experiment we can conclude that 50% of the companies in the urban area are substandard, whereas 50% companies provide standard drugs.