SIMULTANEOUS ESTIMATION OF CEFPODOXIME PROXETIL AND POTASSIUM CLAVULANATE IN TABLET FORMULATION BY RP-HPLC

A new Reversed Phase-High Performance Liquid Chromatographic method was developed and validated for the quantitation of Cefpodoxime proxetil (Cef) and Potassium clavulanate (Pot. clav.)  in pharmaceutical formulations. Determination was performed using a Hypersil-BDS (C_-18) column (5 μm, 250 mm   4.60 mm), a mobile phase containing phosphate buffer (5.5 pH): acetonitrile (51:49 v/v), in isocratic flow rate 1 mL/min. with UV detection at 233.0 nm. The retention time (t_R) for Cef and Pot. clav. were 5.63 min. and 2.49 min. respectively. Linear  relationships were obtained between response and  amount  of  drug  with  high  correlation  coefficients  (r²)  in  the range 1-60 µg mL^-1 for Cef (r² = 0.9966 )  and 0.5-60 µg mL^-1 for Pot. clav. (r² = 0.9954). The method was validated for precision, accuracy and robustness as per ICH guidelines. Inter- and intraday relative standard deviation values for Cef were 0.801% and 0.692% respectively and 0.905% and 1.042% for Pot. clav. respectively. Total recoveries of Cefand Pot. clav. from the tablet formulation were 99.71% and 99.51% respectively. The specificity of the method evaluated by forced degradation studies, suggest that the method could effectively separate the drugs from its degradation products and can be used for stability-indicating analysis.