Application of experimental designs for optimization of forced degradation studies and development of stability-indicating HPTLC method for combination of Cefpodoxime proxetil and Ofloxacin

A stability indicating HPTLC method was developed and validated for fixed dose combination of cefpodoxime proxetil and ofloxacin. TLC plates precoated with silica gel 60F254 were used as stationary phase and n propanol: ammonia (7:3 v/v) was used as mobile phase. Densitometric scanning was carried out at 290nm. Specificity of the method was established by peak purity studies. Method was validated as per ICH guidelines Q2 (R1) for accuracy, precision, linearity, sensitivity and robustness. Both the drugs were subjected to hydrolytic (acidic and basic), oxidative, thermal and photolytic stress as per ICH guidelines Q1A (R2) and Q2B. Forced degradation studies were performed by using design of experiments approach, the most widely used mathematical model. Such experimental design approach can replace conventional trial and error experimentation to achieve optimum degradation.