Simple Stereoselective HPLC Method for Studying the Isomerisation of Cefditoren Pivoxil and Its Isomeric Purity in Pharmaceuticals

A new rapid, simple and stereoselective HPLC method for studying the isomerisation of cefditoren pivoxil in bulk and its isomeric purity in dosage form was developed and validated. This kind of isomerisation could form due to the effect of temperature on analyte during the manufacturing process or improper storage of pharmaceutical formulations. The separation between cefditoren pivoxil and cefditoren ∆3 isomer was obtained with resolution not less than 2.00 in the presence of methanol and phosphate buffer at pH 5.20 (70:30, v:v) onto Luna C18 stationary phase within 15 min analysis time. Under the validated stereoselective HPLC conditions, isomeric purity of cefditoren pivoxil was successfully determined in tablets with inter and intra-days relative standard deviation ≤4.6 %.