RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN AND DIFLUPREDNATE IN THEIR COMBINED DOSAGE FORM

Abstract

Moxifloxacin is synthetic fluoroquinolone antibiotic agent and Difluprednate is a topical corticosteroid indicated for the treatment of infammation and pain associated with ocular surgery. This combination of drugs will be used to treat optical infections. In RP-HPLC method, a mobile phase of Phosphate Buffer (pH 3.5) : Methanol (35:65 v/v) was used to resolve Moxifloxacin and Difluprednate from a mixture. The linearity range obtained for the HPLC method were 25 - 75 μg/ml and 2.5 – 7.5 μg/ml with corresponding correlation coefficient of 0.998 and 0.997, for Moxifloxacin and Difluprednate respectively. Flow rate was set to 1 ml/min and detection was carried out at 244 nm. The method was found to be rapid, accurate and precise. This method was validated according to ICH guidlines.