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.
