A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms

摘要

Fingolimod is an immunosuppressive agent which is used for the prophylaxis of organ transplantation rejection or multiple sclerosis treatment. In this study, systematic forced degradation studies on fingolimod bulk powder were performed to develop a stability-indicating HPLC method. Separation of fingolimod and its degradation products was achieved on a Nova-Pak C8 column. The mobile phase was a mixture of potassium dihydrogenphosphate 50 mM (pH 3.0) and acetonitrile (45:55, v/v) at a flow rate of 1 ml/min. The proposed method was linear in the range of 0.125–20 μg mL⁻¹. The within-day and between-day coefficients of variation were in the range of 0.6–1.2%. The developed method was successfully applied for the determination of the fingolimod amount in pharmaceutical dosage forms.