METHOD DEVELOPMENT AND VALIDATION OF KETOROLAC TROMETHAMINE IN TABLET FORMULATION BY RP-HPLC METHODAbstract
In the 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 × 5 µ). The compound was separated with a solvent mixture of Methanol and water in a ratio of 65:35 v/v with 0.1% O-phosphoric acid as the mobile phase at a flow rate of 1ml/min. The 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 the 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 (r2) of 0.999. The robustness of the method was evaluated by deliberately altering the chromatographic condition. The developed method can be applicable for routine quantitative analysis.
D. A. Khairnar *, C. S. Chaudhari and S. P. Anantwar
Department of Pharmaceutics, M.V.P. Samaj’s College of Pharmacy, Nasik, Maharashtra, India.
28 February 2014
15 April 2014
30 May 2014
01 September 2014