A VALIDATED HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF OFLOXACIN AND DEXAMETHASONE SODIUM PHOSPHATE IN OPHTHALMIC FORMULATION

Naseef K. and Dr. Prasanth S. S.*

ABSTRACT

A liquid chromatographic method was developed and validated for the simultaneous determination of Ofloxacin and Dexamethasone sodium phosphate in bulk and ophthalmic formulations. Ophthalmic preparations contain Benzalkonium Chloride as preservative. It was clearly separated by this method. Optimum separation was achieved in less than 5 min using a C18 column (250 mmx4.6 mm i.d, 5μ particle size) by isocratic elution. The mobile phase consisting of Acetonitrile and water (70:30, v/v) adjusted to pH6.08 with 0.1M acetic acid. Column effluents were monitored at 254 nm at a flow rate of 1.5ml/min. Retention times of Dexamethasone sodium phosphate and Ofloxacin were found to be 1.28 and 2.48 min respectively. The linearity of Ofloxacin and Dexamethasone sodium phosphate was in the range of 3-18 μg/ml and 1-6 μg/ml respectively. Developed method was economical in terms of the time taken and amount of solvent consumed for each analysis. The method was validated and successfully applied to the simultaneous determination of Ofloxacin and Dexamethasone sodium phosphate in bulk and ophthalmic formulations.

Keywords: Ofloxacin, Dexamethasone sodium phosphate, HPLC, Ophthalmic formulation, Validation.