VALIDATED RP- HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DIFLUPREDNATE AND GATIFLOXACIN IN OPTHALMIC EMULSION

A simple, precise, accurate, selective and economical RP-HPLC method has been developed and validated for the simultaneous estimation of difluprednate and gatifloxacin in eye drops formulation. The separation was carried out using a mobile phase consisting of Water and Acetonitrile with pH 2.0 adjusted with orthophosphoric acid in the ratio of 25:75 % v/v. The column used was Shim pack XR ODS II (150 mm x 3 mm id, 5 µm) with flow rate of 1 ml / min using UV detection at 263 nm. The described method was linear over a concentration range of 1-6 ?g/ml and 2-14 ?g/ml for the assay of difluprednate and gatifloxacin respectively. The retention times of difluprednate and gatifloxacin were found to be 5.23 ± 0.0374 and 2.55 ± 0.0296 min respectively. Method was validated statistically and recovery studies were carried out. The proposed method has been applied successfully to the analysis of cited drugs either in pure form or in pharmaceutical formulations with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.