Novel combination of flurbiprofen sodium (FLB) and gatifloxacin (GATI) is available as eye drops form in the ratio of 1:10 and no HPLC method has been reported yet. The present research work aims to develop a simple, sensitive, accurate and reproducible method for the simultaneous estimation of both drugs by the RP-HPLC method, on a C18 column (250×4.6×5 μm) of spinco tech pvt. ltd column was used with a mobile phase containing a mixture methanol: 0.05M phosphate buffer pH-4.2 (50: 50 % v/v). The flow rate was 0.8 ml/min and peaks were monitored at 254 nm and eluted at 5.34 min and 7.94 min for GATI and FLB respectively without interference of blank. The linearity range from 30-70 μg/ml and 30-700 μg/ml for FLB and GATI respectively. The linear regression analysis data for calibration plots shows good linear relationship with R2 value is 0.9999 and 0.9997 and mean % recovery is 99.79% and 99.90 % with the LOD of 0.8831 μg/ml and 2.6990 μg/ml and LOQ is 0.2735 μg/ml and 8.1807 μg/ml for FLB and GATI respectively. Precision (% RSD) is less than 2%. Statistical analysis proves that the method is reproducible and selective for the simultaneous determination of flurbiprofen sodium and gatifloxacin. The results were found to be within acceptance criteria according to ICH Q2 R1 guidelines.
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