A novel stability indicating liquid chromatographic method was developed for the determination of Cefditoren pivoxil in presence of degradation products using Zorbax SB C18 (150 mm × 4.6 mm i.d., 3.5 μm particle size) column with a flow rate 1.0 mL/min (UV detection 210 nm). Linearity was observed over a concentration range 0.1–200 μg/mL with regression equation y = 34809 x + 30603 (R2 = 0.9994). Forced degradation studies were performed and Cefditoren pivoxil is reported to be highly sensitive towards alkaline conditions in comparison to oxidation. The method was validated as per ICH guidelines.
Cefditoren pivoxil, Stability-indicating, Liquid chromatography, Validation, ICH