SIMULTANEOUS ESTIMATION OF CEFPODOXIME PROXETIL AND POTASSIUM CLAVULANATE IN TABLET FORMULATION BY RP-HPLCAbstract
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 (tR) 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.
Shweta B. Dighe
Padmashree Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-18, Maharashtra, India
21 November, 2013
03 January, 2014
26 March, 2014
01 April, 2014