METHOD DEVELOPMENT AND VALIDATION OF KETOROLAC TROMETHAMINE IN TABLET FORMULATION BY RP-HPLC METHOD

ABSTRACT: In present study a simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in Tablet formulation. A gradient HPLC analysis was performed on Grace C18 column (250 cm × 4.6 mm × 5µ). The compound was separated with a solvent mixture of Methanol and water in ratio of 65:35 v/v with 0.1 % O-phosphoric acid as the mobile phase at flow rate of 1ml/min. UV detection was performed at the ʎ max 245 nm. The retention time was found to be 7.70 min. The system suitability parameters such as theoretical plate count, tailing factor and percentage relative standard deviation (RSD) between six standard injections was within the limit. The method was validated according to International conference of harmonization (ICH) guidelines. The linearity was found to be in the concentration range of 5-25 µgm/ml as indicated by correlation coefficient (r 2) of 0.999. The robustness of th