Identification of forced degradation products of lacosamide by LC-QQLIT-MS and LC-IT/TOF-MS

Acta Chromatographicae

Zhou Na¹  Li Tao² 

[1] Department of Pharmaceutical Analysis, School of Pharmacy, Hebei Medical University, Shijiazhuang, 050017;Hebei Entry-Exit Inspection and Quarantine Bureau, Shijiazhuang, 050051

关键词: lacosamide;    forced degradation;    LC–QqLIT-MS;    LC–IT/TOF-MS;    characterization;   

DOI  :  10.1556/1326.2018.00279

学科分类：化学（综合）

来源: Akademiai Kiado Rt.

【 摘 要 】

Lacosamide, a new type of antiepileptic drug, was subjected to forced degradation under the conditions of hydrolysis (acidic and alkaline), oxidation, dry heat, and photolysis to characterize its possible degradation products. The drug showed significant degradation under acidic, alkaline and oxidative conditions. The degradation products were separated on an Agilent Zorbax SB-C18 column with gradient elution using a mobile phase consisting of acetonitrile and ammonium acetate (0.002 mol/L) with formic acid as additive. A combination of liquid chromatography hybrid triple quadrupole-linear ion trap mass spectrometry (LC–QqLIT-MS) and liquid chromatography hybrid ion trap/time-of-flight mass spectrometry (LC-IT/TOF-MS) was used to identify degradation products. A total of 7 products including 4 novel degradation products were characterized. The mechanisms of degradation products of lacosamide were discussed. Application of the method to study degradation products of lacosamide provided fragment information, allowing further investigation of the degradation pathways and intrinsic stability of the drug.

【 授权许可】

Unknown