Abstract
Author(s): P. J. Prasuna Sundari, Anitha kusuma, Prathima Srinivas
Omidria is an ophthalmic injectable of phenylephrine and ketorolac intended for use in cataract surgeries and intraocular lens replacement procedures. Objective of the present study was to develop and validate a specific, accurate, precise RP-HPLC method for the simultaneous estimation of phenylephrine and ketorolac in omidria. The proposed RP- HPLC method utilizes Std BDS C8column (250 mm × 4.6 mm id, 5μm particle size), mobile phase consisting of buffer and acetonitrile in the ratio of (30:70) and a flow rate of 1 ml/min. Quantitation was achieved with PDA detection at 220 nm. Separation was achieved at retention times of 2.313min and 3.090min for phenylephrine and ketorolac respectively. The method was validated as per ICH guidelines for accuracy, precision, linearity, limit of detection, limit of Quantitation and robustness. Limit of detection and limit of Quantitation were determined to be 0.091ppm 0.087ppm; 0.278ppm 0.021ppm for phenylephrine and ketorolac respectively. Linearity was achieved at concentration range of 20-120μg/ml and 6-36μg/ml for phenylephrine and ketorolac. It can be concluded from this study, that the developed RP-HPLC method may be applied in regular analysis for simultaneous estimation of phenylephrine and ketorolac in various dosage formulations.
