Development and optimization of RP-HPLC method for analysis of cefpodoxime proxetil impurity in pharmaceutical formulation

The purpose of this research is to design and validate a unique, simple, effective RP-HPLC analytical method using the QbD methodology. methodology not only confirms method's robustness but also aids in development repeatable reliable data. goal work develop simple for determining Cefpodoxime Impurity (Cefpodoxime Acid) pharmaceutical formulations Analytical Quality by Design (AQbd) accordance with ICH Q8 guidelines. technique was used proposed study. impurity chromatographically evaluated an Inertsil C18 (5 m) column. mobile phase phosphate buffer methanol pH 4.0 ratio 60:40, which driven onto column at 0.8 ml/min isocratic elution protocol. 222 nm discovered be detection wavelength estimation. expert 11 (Trial edition) software investigate effects composition, flow rate, pH. analysis cefpodoxime acid took 20 minutes complete & 15.6 minutes, eluted.