This study describes the formulation of immediate release Ketorolac tromethamine (KT) 10 mg tablet by direct compression method; evaluation of their compliance to various Pharmacopoeial quality control parameters i.e. weight variation, friability, hardness, thickness, moisture content, disintegration, assay and dissolution; and their comparison with 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. The physical mixtures of the drug and the excipients were evaluated for their micrometric properties. Quality evaluation of the five different formulations and randomly selected four different brands of KT 10 mg tablets purchased from local market (coded as LKT1, MKT2, MKT3 and SKT4) were performed according to Pharmacopoeia. The results were obtained by UV-Vis 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 except SKT4 which showed excessive moisture content of 7.18%.None of the tested brands of KT were found to be pharmaceutically equivalent whereas three developed formulation were pharmaceutically equivalent with the in house benchmark (MKT2) from which their interchangeability can be suggested.
Key words: Ketorolac tromethamine; direct compression; immediate release; quality evaluation; pharmaceutical equivalence; UV-Vis spectroscopy.
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