Validated LC-MS/MS method for quantification of agomelatine in human plasma and its application in a pharmacokinetic study

被引:20
作者
Patil, Satish R. [3 ,4 ]
Nerurkar, Ketan K. [4 ]
Kalamkar, Ashok M. [4 ]
Pukale, Vishwas [3 ,4 ]
Mangaonkar, Kiran V. [1 ,2 ]
Pingale, Satish G. [1 ,2 ]
机构
[1] Mithibai Coll Arts, Analyt Chem Res Lab, Chauhan Inst Sci, Bombay 400056, Maharashtra, India
[2] Amrutben Jivanlal Coll Commerce & Econ, Bombay 400056, Maharashtra, India
[3] SVKMS NMIMS Univ, Dept Pharmacol, Bombay 400056, Maharashtra, India
[4] Drug Monitoring Res Inst, Rabale 400701, Navi Mumbai, India
来源
JOURNAL OF MASS SPECTROMETRY | 2012年 / 47卷 / 01期
关键词
liquid-liquid extraction; tandem mass spectrometry; agomelatine; human plasma; pharmacokinetic study;
D O I
10.1002/jms.2020
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
An analytical method based on liquidliquid extraction has been developed and validated for analysis of agomelatine in human plasma. Fluoxetine was used as an internal standard for agomelatine. A Betasil C18 (4.0 x 100mm, 5 mu m) column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic conditions and mass spectrometric detection in the positive ionization mode using an API-4000 system. The proposed method has been validated with linear range of 0.050-8.000 ng/ml for agomelatine. The intra-run and inter-run precision values are within 12.12% and 9.01%, respectively, for agomelatine at the lower limit of quantification level. The overall recovery for agomelatine and fluoxetine was 67.10% and 72.96%, respectively. This validated method was used successfully for analysis of plasma samples from a pharmacokinetic study. Copyright (C) 2012 John Wiley & Sons, Ltd.
引用
收藏
页码:23 / 28
页数:6
相关论文
共 7 条
[1]  
European Commission, 2010, CPMPEWPQWP140198REV1, P13
[2]  
Lôo H, 2003, ENCEPHALE, V29, P165
[3]  
Rao V., 2010, RES J PHARM BIOL CHE, V1, P446
[4]   N-[2-(7-METHOXY-1-NAPHTHYL)ETHYL]ACETAMIDE, A POTENT MELATONIN ANALOG [J].
TINANT, B ;
DECLERCQ, JP ;
POUPAERT, JH ;
YOUS, S ;
LESIEUR, D .
ACTA CRYSTALLOGRAPHICA SECTION C-CRYSTAL STRUCTURE COMMUNICATIONS, 1994, 50 :907-910
[5]  
US FDA, 2001, GUID IND BIOAN METH
[6]  
Xue jun H., 2010, W CHIN J PHARM SCI, V2, P37, DOI CNKI:SUN
[7]  
HXYO.0.2010-02-037