Forced degradation of fingolimod_ Effect of co-solvent and英文学习资料 .pdfVIP

Journal of Pharmaceutical and Biomedical Analysis 115 (2015) 388–394 Contents lists available at ScienceDirect Journal of Pharmaceutical and Biomedical Analysis j o u r n a l h o me p a ge : w w w. elsev /lo ca t e /j p b a Forced degradation of fingolimod: Effect of co-solvent and characterization of degradation products by UHPLC-Q-TOF–MS/MS and 1H NMR Prinesh N. Patel a , Pradipbhai D. Kalariya a , S. Gananadhamu a,∗∗ , R. Srinivas a,b,∗ a Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, 500037, Telangana, India b National Centrefor Mass Spectrometry, CSIR-Indian Institute of Chemical Technology, Hyderabad, 500007, Telangana, India a r t i c l e i n f o a b s t r a c t Article history: Fingolimod (FGL), an immunomodulator drug for treating multiple sclerosis, was subjected to hydrolysis Received 13 March 2015 (acidic, alkaline and neutral), oxidation, photolysis and thermal stress, as per International Conference Received in revised form 12 July 2015 on Harmonization specified conditions. The drug showed extensive degradation under base hydroly- Accepted 22 July 2015 sis, however, it was stable under all other conditions. A total of three degradation products (DPs) were Available online 26 July 2015 observed. The chromatographic separation of the drug and its degradation products was achieved on a Fortis C18 (100 ×2.1 mm, 1.7 m) column with a mobile phase composed of 0.1% formic acid