A Validated Stability Indicating RP-HPLC Method for Cefditoren Pivoxil in Bulk Drug and Pharmaceutical Dosage Form

A reverse phase HPLC method has been developed and validated for estimation of Cefditoren Pivoxil (CFDT) in its pharmaceutical dosage form. The proposed method utilizes a Phenomenex Luna C18 (150 mm ×4.6 mm, 5 μm particle size), mobile phase consisting Acetonitrile: Water (50: 50, v/v) with apparent pH adjusted to 3.5 and UV detection at 230 nm using photo diode array detector. CFDT and its drug product were exposed to hydrolytic, oxidative and Neutral stress conditions and the stressed samples were analysed by proposed method. Peak homogeneity data of CFDT peaks obtained using photodiode array detector in the stressed sample chromatograms, demonstrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 20–120 μg/ml for CFDT. The mean recovery was 98.77–101.29% for CFDT.