In vitro Pharmaceutical Equivalence Study of Three Brands of Atenolol Tablets Available in Bangladesh

Abstract

The aim of the present work was to assess the pharmaceutical equivalence of three brands of atenolol
(50 mg) tablets available in Bangladesh using in vitro dissolution study. The dissolution study was carried out using
the paddle apparatus according to the guidelines of United States Pharmacopoeia (USP). The dissolution profiles of
three locally manufactured atenolol tablets were determined and compared with the dissolution profile of atenolol
tablet from innovator’s company. All samples attained more than 85% dissolution within 10 minutes. Mean
dissolution values were employed to estimate difference factor (f1) and similarity factor (f2). Difference factor (f1) and
similarity factor (f2) were used to assess in vitro bio-equivalency among the three brands. Other general quality
assessment parameters such as hardness, friability and disintegration time were also determined. All brands complied
with the official specifications for hardness, friability and disintegration time. The study indicated that all brands can
be prescribed interchangeably.