Abstract

This study aims to evaluate the quality parameters of the immediate release Ketorolac tromethamine (KT) 10 mg tablet of different local brands available in Bangladesh. The evaluation was done in compliance to various Pharmacopeial quality parameters, i.e., weight variation, friability, hardness, thickness, disintegration, potency, and dissolution. Six formulations of KT were prepared by direct compression method using different super disintegrants. Micrometric properties of the mixtures of the drug and the excipients prepared for formulation were evaluated. Quality evaluation of the six different formulations and randomly selected six different brands of KT 10-mg tablets purchased from the local market were performed according to Pharmacopoeia. The results were obtained by UVVis spectrophotometer and all the dissolution profiles were characterized by the zero order kinetics. All the brands of KT and developed formulations met the official specification with some fluctuations in the range. The marketed ketorolac tablet’s potency ranged from 93% to 97% and formulated tablets is 91.15%. The values obtained from the tests were used to analyze the degree of conformance of commercially available drugs to the USP specification that represents the quality of both commercially available and formulated tablets. All the parameters comply with the USP specifications which ensure the safe usage of ketorolac tablets in Bangladeshi population that doesn’t compromise with the quality

Keywords

Ketorolac tromethamine, marketed tablet, immediate release, quality evaluation, pharmaceutical equivalency