Identification of Related Substances in Citicoline Sodium Injection by HPLC-DAD and HPLC-MS/MS

摘要

In the present study a method based on liquid chromatography with diode array detection (HPLC-DAD) coupled to an electrospray ionization (ESI) interface for identify the chemical structures of related substances in citicoline sodium injection was established. There are seven impurities in a typical chromatogram of citicoline sodium injection (5'-CMP has known). The UV spectrum and molecular weight of related substances were obtained and the chemical structures were presumed according to production process. Compared with reference substances, two impurities were confirmed as cytosine and cytidine. As for the largest related substance (except 5'-CMP), it was collected by liquid chromatography and treated by solid-phase extraction for LC-MS system. Compared with self made reference substance, it was confirmed as uridine diphosphate choline. The three main related substances were identified in citicoline sodium injection for the first time.