ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BROMFENAC SODIUM AND MOXIFLOXACIN IN THEIR COMBINED DOSAGE FORM

Abstract

A simple, rapid, accurate and precise method was developed for Bromfenac sodium and Moxifloxacin. BDS Hypersil C-18 column (250 mm × 4.6 mm id) 5 $\mu$ m particle size was used as stationary phase. The mobile phase used was Buffer KH2PO4: Acetonitrile : Triethylamine at pH 4.0 adjusted with Ortho phosphoric acid. The mobile phase was delivered at flow rate 1.0 ml/min. UV detection was set at 275 nm. The retention time for Bromfenac sodium and Moxifloxacin was found 4.637 minutes and 7.630 minutes respectively. The linearity was observed over the range of 2.25-6.75 mcg/ml and 12.5-37.5 mcg/ml for Bromfenac sodium and Moxifloxacin respectively. The LOD was found 0.46 mcg/ml and 0.64 mcg/ml for Bromfenac sodium and Moxifloxacin respectively; whereas LOQ was found to be 1.41 mcg/ml for Bromfenac sodium and 1.94 mcg/ml for Moxifloxacin. Moreover, the % RSD for repeatability, Inter and intra-day precision was found to be less than 2 % which reveals method is precise. The correlation co-efficient found to be 0.997 and 0.999 for Bromfenac sodium and Moxifloxacin respectively. The % recovery was found to be 99.79-100.09 % for Bromfenac sodium and 99.90-100.03 % for Moxifloxacin. The assay percentage was found to be 98.65 % and 97.50 % for Bromfenac and Moxifloxacin respectively. All the validation parameters were checked according to ICH guidelines finally it is concluded that the developed method is precise and accurate.