Determination of degradation products of sumatriptan succinate using LC-MS and LC-MS-MS

被引:30
作者
Xu, XH [1 ]
Bartlett, MG [1 ]
Stewart, JT [1 ]
机构
[1] Univ Georgia, Coll Pharm, Dept Pharmaceut & Biomed Sci, Athens, GA 30602 USA
关键词
sumatriptan succinate; LC-MS; LC-MS-MS; stability; degradation pathway; degradant identification;
D O I
10.1016/S0731-7085(01)00409-5
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Acid, base, heat, oxidation and UV irradiation stress methods were applied to study the stability of the bulk drug form of sumatriptan succinate. Liquid chromatography coupled with mass spectrometry (LC-MS and LC-MS-MS) was used to analyze the degraded samples and tentative structural identifications were assigned based upon known reactivity of the drug, molecular weight measurements and MS-MS fragmentation patterns. Sumatriptan succinate was found to be stable to exposure of acid, base, oxidation and UV irradiation at ambient conditions, but was found to degrade under acidic, basic and oxidative conditions when heated to 90 degreesC. (C) 2001 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:367 / 377
页数:11
相关论文
共 18 条
[1]   SUMATRIPTAN [J].
BATEMAN, DN .
LANCET, 1993, 341 (8839) :221-224
[2]   Validation of a liquid chromatographic tandem mass spectrometric method for the determination of sumatriptan in human biological fluids [J].
Cheng, KN ;
Redrup, MJ ;
Barrow, A ;
Williams, PN .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1998, 17 (03) :399-408
[3]  
Deshpande, 1998, INDIAN DRUGS, V35, P404
[4]   A method using a liquid chromatographic electrospray mass spectrometric assay for the determination of antimigraine compounds: Preliminary pharmacokinetics of MDL 74,721, sumatriptan and naratriptan, in rabbit [J].
Dulery, BD ;
Petty, MA ;
Schoun, J ;
David, M ;
Huebert, ND .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1997, 15 (07) :1009-1020
[5]   Fully automated assay for the determination of sumatriptan in human serum using solid-phase extraction and high-performance liquid chromatography with electrochemical detection [J].
Dunne, M ;
Andrew, P .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1996, 14 (06) :721-726
[6]   Stability of sumatriptan succinate in extemporaneously prepared oral liquids [J].
Fish, DN ;
Beall, HD ;
Goodwin, SD ;
Fox, JL .
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 1997, 54 (14) :1619-1622
[7]   Determination of sumatriptan succinate in human plasma by highperformance liquid chromatography with coulometric detection and utilization of solid-phase extraction [J].
Franklin, M ;
Odontiadis, J ;
Clement, EM .
JOURNAL OF CHROMATOGRAPHY B-BIOMEDICAL APPLICATIONS, 1996, 681 (02) :416-420
[8]  
*ICH STEER COMM, 1999, CONS STEP 2 ICH OCT
[9]   Serotonin 1(D) (5-HT1D) agonists and other agents in acute migraine [J].
Mathew, NT .
NEUROLOGIC CLINICS, 1997, 15 (01) :61-&
[10]   Quantitation of the 5HT(1D) agonists MK-462 and sumatriptan in plasma by liquid chromatography atmospheric pressure chemical ionization mass spectrometry [J].
McLoughlin, DA ;
Olah, TV ;
Ellis, JD ;
Gilbert, JD ;
Halpin, RA .
JOURNAL OF CHROMATOGRAPHY A, 1996, 726 (1-2) :115-124