Development and validation of Immunomodulating drug Fingolimod by RPHPLC method with detailed force degradation study

Abstract

Fingolimod is a sphingosine -1-phosphate modulator as well as reduces the infiltration of pathogenic lymphocyte cells into the central nervous system because they involved in nervous tissue damage and nerve inflammation. Here we reported sensitive, precise, accurate and time saving chromatographic separation method of Fingolimod and its degraded products which were performed on RP-HPLC. The separation was performed using Sunfire C18 column (250 x 4.6 mm i.d.) having 5 μm particle size. The mobile phase used for the elution was Buffer: Acetonitrile (35: 65 v/v). Eluting compounds were monitored at 220 nm wavelength with UV-Visible detector. The developed procedure has been evaluated for the specificity, linearity, accuracy, precision, limit of detection, limit of quantification and robustness in order to ascertain the stability of the analytical method.