Reversed phase high performance liquid chromatographic method for simultaneous determination of phenylephrine hydrochloride and ketorolac tromethamine

Abstract

A simple, sensitive, accurate and rapid reversed phase high performance liquid chromatographic method was developed for simultaneous determination of phenylephrine hydrochloride (PHE) and ketorolac tromethamine (KTC). The method was performed on an Eclipse plus C18 reversed phase column (100 mm × 4.6 mm, particle size 3.5 µm) using a mobile phase consisting of methanol: potassium dihydrogen ortho phosphate buffer; pH 6.5 in a ratio of 50:50 (v/v).  The flow rate was 1 ml/min and detection was carried out at 277 nm for phenylephrine and 320 nm for ketorolac. The retention times of phenylephrine hydrochloride and ketorolac tromethamine were 1.03 and 2.68 min, respectively. The method was linear over the concentration range of 3-60 μg/ml for phenylephrine and 1.5-21 μg/ml for ketorolac. The described HPLC method was successfully applied for the determination of phenylephrine and ketorolac in laboratory prepared mixture containing all possible excipients present in eye drop dosage form. The mean percentage recovery was found to be 100.23% for phenylephrine and 99.74% for ketorolac. Validation of the method was carried out according to the guidelines of the International Conference of Harmonization (ICH).