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ISSN 2063-5346
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Development and validation of an analytical method for the simultaneous quantification of dexamethasone and ketorolac tromethamine in ophthalmic solution using reverse-phase high-performance liquid chromatography

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Uma Shanker Maurya*1, Anju Goyal
» doi: 10.48047/ecb/2023.12.5.309

Abstract

A reverse-phase high-performance liquid chromatography method was developed to simultaneously determine dexamethasone and Ketorolac Tromethamine in Pharmaceutical marketed preparation. The kromasil C18 (250 mm x 4.6mm) column achieved the reverse phase high-performance liquid chromatographic separation. Methanol and 0.1% orthophosphoric acid in the ratio of 65:35 v/v, were selected as mobile phases with a flow rate of 1mL min-1. The detection wavelength was 283 nm. Dexamethasone and ketorolac tromethamine had retention times of 4.87 and 5.96, respectively. According to the international conference on harmonization's guidelines for linearity, accuracy, precision, detection limit, quantification limit, and robustness, the method was validated. Linearity was seen for dexamethasone and ketorolac tromethamine at 2-30 μg mL-1 and 10-150 μg mL-1, respectively. The established approach was proven to be accurate, precise, and sensitive for the simultaneous quantification of dexamethasone and ketorolac tromethamine in pharmaceutically marketed preparations.

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