In vitro quality assessment of ketotifen fumarate tablets commercially available in Bangladesh

Abstract

Quality defines the standard of a product and every company strives to achieve it, although it is often challenging. Quality of pharmaceutical products is very important for achieving the therapeutically activity of the standard drugs. This research work was aimed to investigate the quality control parameters of five brands of ketotifen that are available in the market. The five ketotifen brands were collected from the Bangladeshi local market, after which they underwent various physical parameter assessments including weight variation, hardness, friability, potency, disintegration, and acid-base degradation assessments. The brands passed the tests as no tablets crossed the ±10 % weight variation. The percentage friability of the five brands was less than 1%, hence they satisfied the standards. The disintegration time of the tablets did not exceed 5 minutes; therefore, they met the standards. All the brands showed potency ranging from 90 to 110%. In the degradation studies, no products met the USP specified limit. The average hardness of all brands did not meet the standard criterion.