Comparative Performance Evaluation of Different Brands of Ketorolac Tromethamine (NSAID’S) Generic Tablets by Sanjida Jannath, Israt Nayeema, Nishat Jahan and Kanij Nahar Deepa*in Advancements in Bioequivalence & Bioavailability (ABB)
Ketorolac tromethamine is a highly potent non steroidal anti-inflammatory agent that inhibits the enzyme cyclo-oxygenase and decreases the synthesis of prostaglandins. It is mainly used for the treatment of inflammation and pain. The study was carried to compute the comparative in-vitro quality control parameters through the assessment of weight variation, friability, hardness and disintegration time and dissolution profile among the different brands of Ketorolac that are available in local market of Bangladesh. To evaluate the quality parameters, six different brands of Ketorolac 10mg tablets were selected and general quality parameters like weight variation, hardness, friability as well as in-vitro dissolution test, potency, disintegration time was carried out. Friability was found less than 1% in all brands. No noteworthy dissimilarity was found in disintegration time as they disintegrated within 5 to 30 minutes. Dissolution profile of all brands was not less than 75% of drug in 45 minutes which denotes better dissolution time in dissolution media (distilled water). It was monitored that four different brand of Ketorolac tablets were in accordance with USP guideline, except KTR3 (219.66N) and KTR6 (192.09N). The assay determines that potency of all brands was within 91.87% to 100.2%. All brands are within the limit of potency except brand KTR2 (91.87) and KTR4 (94.85) as stated by the USP specification. This study recommended that most commercially convenient Ketorolacdeduced standard quality with USP specification. It also concluded that quality parameters should be maintained not only for Ketorolac but also for all kinds of medicine for getting higher quality drug products.
