Forced degradation of fingolimod: Effect of co-solvent and characterization of degradation products by UHPLC-Q-TOF-MS/MS and 1H NMR

- Forced degradation study of fingolimod was carried out as per ICH guidelines.
- The drug degraded in base hydrolysis to form three degradation products (DPs).
- DPs were characterized by LC-Q-TOF-MS/MS and NMR.
- Acetonitrile as co-solvent in stress studies reacted and formed acetylated DPs.