Simple and sensitive method for the analysis of ketorolac in human plasma using high-performance liquid chromatography

Objective: To develop a simple and sensitive method of ketorolac in drug free human plasma using high-performance liquid chromatographic (HPLC). Method: Ketorolac from blank plasma was extracted using protein precipitation method. Trichloro acetic acid (10%) was used as a protein precipitating agent and the percentage of recovery was calculated by adding known volume of dexibuprofen as internal standard. The HPLC separation was achieved on reversed-phase C₁₈ column and the separations were detection by Photodiode Array (PDA) detector at 306 nm. Acetonitrile and 5 mM ammonium acetate (pH 3.5), in the ratio of 60:40% v/v was used as mobile phase at the isocratic flow rate of 1.0 ml/min. The method was validated according to FDA Guidance for Industry. Result: The percentage of recovery of ketorolac was 93.7 ± 0.12 (mean ± SD; n = 5). The linearity was achieved in this method range of 10.0-125.0 ng/ml with regression coefficient range of 0.999. Conclusion: Ketorolac bioanalytical method was developed and validated according to FDA Guidance for Industry.

Key words: Dexibuprofen, Ketorolac, Pharmacokinetics.