Identification and characterization of stress degradants of lacosamide by LC-MS and ESI-Q-TOF-MS/MS: Development and validation of a stability indicating RP-HPLC method

被引:14
作者
Ramisetti, Nageswara Rao [1 ]
Kuntamukkala, Ramakrishna [1 ]
Lakshetti, Sridhar [2 ]
Sripadi, Prabhakar [2 ]
机构
[1] IICT, Div Analyt Chem, HPLC Grp, Hyderabad 500007, Andhra Pradesh, India
[2] IICT, Natl Ctr Mass Spectrometry, Hyderabad 500007, Andhra Pradesh, India
关键词
ESI-MS/MS; Forced degradation; Lacosamide; RP-HPLC; Stability indicating; ANTIEPILEPTIC DRUG; IMPURITIES; PRODUCTS; QUANTIFICATION; SEPARATION; PLASMA;
D O I
10.1016/j.jpba.2014.03.010
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
The current study dealt with the degradation behavior of lacosamide (LAC) under ICH prescribed stress conditions. LAC was found to be labile under acid and base hydrolytic stress conditions, while it was stable to neutral hydrolytic, oxidative, photolytic and thermal stress. In total, seven degradation products (DPs) were formed, which were separated on a C-18 column using a stability-indicating method. LC-MS analyses indicated that one of the DPs had the same molecular mass as that of the drug. Structural characterization of DPs was carried out using ESI-Q-TOF-MS/MS technique. The degradation pathways and mechanisms of degradation of the drug were delineated by carrying out the degradation in different co-solvents viz. methanol, deuterated methanol, ethanol, 1-propanol and acetonitrile. The developed LC method was validated for the determination of related substances and assay of LAC as per ICH guidelines. This study demonstrates a comprehensive approach of LAC degradation studies during its development phase. (C) 2014 Published by Elsevier B.V.
引用
收藏
页码:256 / 264
页数:9
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