PURPOSE: Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA METHODS: The developed process involves extracting ketorolac and its internal standard (ketorolac- RESULTS: The validated method can be successfully applied for quantitation of ketorolac over a concentration range of 2.5 ng/mL to 5000 ng/mL. The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability. CONCLUSIONS: The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial.