Degradation Study of Ketorolactromethamine by a Validated UPLC Method

Abstract

UPLC stability indicating method was developed for determining ketorolac tromethamine in its degradation study at different conditions. An isocratic mobile phase composition of 60:10:30 (v/v) containing CH3OH, CH3CN and 5mM NaH2PO4 and C18 column were used at a flow rate of 0.20 mL min-1. Satisfactory retention time was found 2.13±0.05 min at 320 nm when monitored by DAD detector. Forced degradation studies of ketorolac tromethamine was also performed at the following conditions: acid and basic hydrolysis, heat (50-70°C for 1 hr), photolytic (UV and sunlight for up to 3 hr), oxidation (3% hydrogen peroxide for 1 hr). Forced degradation study revealed that ketorolac degraded significantly under thermal conditions. In 1N acid and base hydrolysis, degradation was moderately significant and comparable. It was degraded marginally in 0.1N acid-base hydrolysis which was comparable to oxidative conditions. But in photolytic condition ketorolac shows insignificant degradation. Method was also applied to pharmaceutical formulation.