Quality by design approach for development of stability indicating method for determination of cefditoren pivoxil
Sawsan Mohamed Amer
Cairo University, Egypt
: J Diagnos Tech Biomed Anal
Abstract
A hybrid development strategy of Quality by design (QbD) and one factor at time (OFAT) approaches was used to develop a stability indicating HPLC method for quantitative determination of cefditoren pivoxil (CTP) in bulk powder and pharmaceutical formulations. A forced degradation studies were performed under acid, alkaline, thermal and photolytic stress conditions. Chromatographic separation achieved in less than 10 min. using a RP C-18 column, mobile phase [methanol: acetate buffer pH 4.5 (55:45, v/v)], flow rate 1.5 mL min-1 and UV detection at 225 nm. Optimization of column, pH, and wavelength implemented according to OFAT approach, while elution temperature and methanol content in the mobile phase considering QbD approach. The method was validated to meet official requirements including specificity, linearity, precision, accuracy and robustness. The drug response was linear (r=0.9999) in range of 89-672 μg mL-1, the limit of detection (LOD) and limit of quantitation (LOQ) were 5.31 μg mL-1 and 16.1 μg mL-1, respectively. The intra- and inter-day precisions were 0.11%, 0.44% respectively. The proposed method was successfully applied for the determination of CTP in bulk and tablets with acceptable accuracy and precisions. The obtained results demonstrated that the proposed method has a great value for application in quality control labs and stability studies for CTP.
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