Comparative in vitro bioequivalence study of different export brands of losartan potassium tablet

Abstract

As a pre-requested requirement for importing any medicine to any country or in Bangladesh point of view for any types of medicines export the company have to submit in-vivo bioequivalence study report. However according to Shargel Waivers of in-vivo Bioequivalence studies (Biowaivers), in some cases, in-vitro dissolution testing may be used in lieu of in-vivo bioequivalence studies. The aim of the present study is to evaluate the bioequivalence quality of different brands of Losartan potassium that are regularly exported to several foreign countries. Three different brands of Losartan potassium of Bangladesh as well as one patented drug are tested according to BP/USP specified procedure where USP apparatus II was used. The result showed that, three brands of Losartan Potassium tablets meet the USP specification. All brands tested, showed a good result for dissolution rate.