ABSTRACT
This study describes the formulation of immediate release Ketorolac tromethamine (KT) 10-mg tablet by directcompression method; evaluation of their compliance to various Pharmacopoeial quality parameters, i.e., weightvariation, friability, hardness, thickness, moisture content, disintegration, assay, and dissolution; and their comparisonwith marketed brands for determination of pharmaceutical equivalency. Five formulations of KT were prepared(coded as FKT1, FKT2, FKT3, FKT4, and FKT5) by direct compression method using different superdisintegrants.Micrometric properties of the mixtures of the drug and the excipients prepared for formulation were evaluated. Qualityevaluation of the five different formulations and randomly selected four different brands of KT 10-mg tablets purchasedfrom the local market (coded as LKT1, MKT2, MKT3, and SKT4) were performed according to Pharmacopoeia. Theresults were obtained by UV-Vis spectrophotometer and all the dissolution profiles were characterized by the zeroorder kinetics. All the brands of KT and developed formulations met the official specification except SKT4 whichshowed excessive moisture content of 7.18%. None of the tested brands of KT were found to be pharmaceuticallyequivalent, whereas two developed formulation were pharmaceutically equivalent with the in house benchmark(MKT2) from which their interchangeability can be suggested.