Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RPHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFPODOXIME PROXETIL AND LEVOFLOXACIN IN THEIR COMBINED DOSAGE FORM

Shivangi D. Patel*, Farhatjahan Shaikh

ABSTRACT

A simple, rapid, precise and accurate stability-indicating reversed phase (RP) HPLC method was developed and validated for simultaneous estimation of Cefpodoxime proxetil and Levofloxacin in therir combined tablet dosage form. The method has shown adequate separation of Cefpodoxime proxetil and Levofloxacin from their degradation products. Separation was achieved on a C18(100 mm x 4.6 mm,i.d., 3.5μm) column, kept at ambient temperature, using a mobile phase consisting of 50mM Ammonium acetate buffer : acetonitrile : triethylamine (60:40:0.2 v/v/v), pH 6.0 adjusted with glacial acetic acid at a flow rate of 1.0 ml/min and UV detection at 258 nm. The average retention times for Cefpodoxime proxetil isomer A, Cefpodoxime proxetil isomer B and Levofloxacin were found to be 5.70, 6.304 and 1.29 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, Levofloxacin in the range of 8-24 and 10-30 μg/ml respectively. 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 100.58-101.32 % and 99.91-100.32 % respectively. The method was found to be specific and stability indicating as no interfering peaks of degradants and excipients were observed.

Keywords: Cefpodoxime proxetil, Levofloxacin, forced degradation, degradation products, Stability indicating method, RP-HPLC.