APPLICATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF RACECADOTRIL AND OFLOXACIN IN THEIR PHARMACEUTICAL DOSAGE FORM

Racecadotril and ofloxacin are co-formulated for treatment of acute symptomatic diarrhea. In the present work RP-HPLC method was developed for simultaneous determination of racecadotril and ofloxacin in the combined dosage form. An isocratic separation was carried out on BDS Equisil  C18 (150 X 4.6 mm, 5 μm particle size) reversed phase column with a mobile phase consists of water and acetonitrile in the ratio of (20:80 % v/v) and pH 3 maintained by 0.1% ortho phosphoric acid. The flow rate was 1 ml/min and UV detection at 230 nm. The linear regression analysis of the calibration graphs showed a good linear relationship over a concentration range of 5-25 μg/ml with main recovery percent 100.06±0.952 and 99.93±0.798 for racecadotril and ofloxacin, respectively. The proposed method was validated according to ICH guidelines, and has been successfully applied for simultaneous determination of both drugs in both bulk and commercial dosage form.