Development and Validation of Stability Indicating HPTLC Method for Determination of Ofloxacin and Ketorolac Tromethamine in Combination

Abstract

Ofloxacin is synthetic fluoroquinolone and broad spectrum antimicrobial agent for oral administration. Ketorolac is an non selective cyclooxygenase(COX) inhibitor and has anti-inflammatory, antipyretic and analgesic effects. The present study describes degradation of Ofloxacin and Ketorolac under ICH [Q1A (R2)] prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for both Ofloxacin and Ketorolac when each was exposed to different stress condition. For HPTLC, aluminium plate precoated with Silica Gel 60 F254 and mobile phase consisting of n- butanol : ethanol : ammonia 6: 1: 3 v/v/v was used to achieve separation. Quantitation was done at 310 nm. The method was validated as per ICH Q2 R1 guidelines and results were in limit.The method was found to be simple, specific, precise, and stability indicating.