Stability Indicating Assay Method Development of Fingolimod

Stress testing of Fingolimod capsules was carried out under acidic, alkaline, peroxide, photolytic, and dry heat conditions. The stressed sample and standard drug were subjected to chromatographic separation and the conditions required for resolving the drug peak from any potential degradation products were optimized. The HPLC analysis of Fingolimod Capsules was carried out using X-Bridge (250mm x 4.6 mm, 5µm) during the stress studies Fingolimod Capsules were found to be stable degrade under acidic, alkaline, peroxide, photolytic and heat conditions. The degradation products and tablet excipients were well resolved from the drug using mobile phase comprising of Buffer:ACN (30:70v/v). The detection wavelength was 220 nm. The developed method was validated as per ICH Guide lines. The method was found to be accurate, precise, robust and linear in the range of 2-14µg/ml. Accuracy was calculated at three levels:50 %, 100%, 150% and recovery was found to be between 95-105%. It can be concluded that the HPLC method developed for Fingolimod Capsules is capable of discriminating between the drug and degradation products.