A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFPODOXIME AND LEVOFLOXACIN IN BULK AND FORMULATION

A simple, rapid, precise and accurate stability-indicating reverse phase HPLC method was developed and validated for simultaneous estimation of Cefpodoxime proxetil and Levofloxacin in bulk and formulation. The method has shown adequate separation of Cefpodoxime proxetil and Levofloxacin from their degradation products. Separation was achieved on ACE (250 mm x 4.6 mm, 5 μ) column, kept at ambient temperature, using a mobile phase consisting of 0.01M Ortho phosphoric acid and Methanol (40:60) at a flow rate of 1.2 ml/min and UV detection at 275 nm. The average retention times for Cefpodoxime proxetil and Levofloxacin were found to be 3.068 and 3.870 min respectively. Cefpodoxime proxetil, Levofloxacin and their combination drug product were subjected to acid hydrolysis, base hydrolysis, oxidation, thermal and photolytic stress conditions. Validation of the method was carried out as per ICH guidelines. Linearity was established for Cefpodoxime proxetil and Levofloxacin in the range of 2.5-7.5 μg/mL . Correlation coefficient was found to be 0.9997 and 0.9994 for Cefpodoxime proxetil and Levofloxacin respectively. The percentage recovery of Cefpodoxime proxetil and Levofloxacin was found to be in the range of 98.0 - 102.0 %. The method was found to be specific and stability indicating as no interfering peaks of degradants and excipients were observed.