Development and Validation of a new HPLC method for the estimation of Citicoline and Piracitam and Characterization of its Degradants using LC-MS/MS

A new HPLC method was developed and validated for the separation and analysis of Citicoline and Piracitam degradation products were characterized using LC-MS/MS. The chromatographic method was optimized using specimens generated by stress degradation. On a Inertsil ODS (150x4.6mm, 3.5µ)Vcolumn with connected to a PDA detector, and by using a linear mobile phase gradient prepared from trifluoroacetic acid (0.1%) in water and acetonitrile, with a flow rate of 1.0 mL/min and detection at 231 nm, good resolution of the analyte peak was obtained from peaks belongs to degradation products. Excellent accuracy, precision, and linearity results were obtained for Citicoline and Piracitam. When the forced test solutions were analyzed by comparison with the Citicoline and Piracitam. working standard the mass balance was always close to 99.4%, indicating the method was well stabilized and validation was performed under ICH requirements. LOD and LOQ were well established, and the correlation coefficient of Citicoline and Piracitam was 0.999.