Quantification of granisetron in human plasma by liquid chromatography coupled to electrospray tandem mass spectrometry

被引:13
作者
Nirogi, Ramakrishna V. S. [1 ]
Kandikere, Vishwottam N. [1 ]
Shukla, Manoj [1 ]
Mudigonda, Koteshwara [1 ]
Maurya, Santosh [1 ]
Boosi, Ravikumar [1 ]
机构
[1] Suven Life Sci Ltd, Biopharmaceut Res, Hyderabad 500034, Andhra Pradesh, India
关键词
granisetron; electrospray ionization; liquid chromatography-tandem mass spectrometry; pharmacokinetic study;
D O I
10.1002/bmc.613
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A simple, sensitive and rapid high-performance liquid chromatography/electrospray ionization tandem mass spectrometry method was developed and validated for the assay of granisetron in human plasma. Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reversed-phase C-18 column and analyzed by MS in the multiple reaction monitoring mode using the respective [M+H](+) ions, m/z 313/138 for granisetron and m/z 409/228 for the IS. The assay exhibited a linear dynamic range of 0.1-20 ng/mL for granisetron in human plasma. The lower limit of quantification was 100 pg/mL with a relative standard deviation of less than 5%. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies. Copyright (c) 2006 John Wiley & Sons, Ltd.
引用
收藏
页码:888 / 897
页数:10
相关论文
共 30 条
[1]   Granisetron: An update on its clinical use in the management of nausea and vomiting [J].
Aapro, M .
ONCOLOGIST, 2004, 9 (06) :673-686
[2]   CHARACTERIZATION OF THE CYTOCHROME-P450 ENZYMES INVOLVED IN THE IN-VITRO METABOLISM OF GRANISETRON [J].
BLOOMER, JC ;
BALDWIN, SJ ;
SMITH, GJ ;
AYRTON, AD ;
CLARKE, SE ;
CHENERY, RJ .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1994, 38 (06) :557-566
[4]   Direct plasma liquid chromatographic-tandem mass spectrometric analysis of granisetron and its 7-hydroxy metabolite utilizing internal surface reversed-phase guard columns and automated column switching devices [J].
Boppana, VK ;
MillerStein, C ;
Schaefer, WH .
JOURNAL OF CHROMATOGRAPHY B-BIOMEDICAL APPLICATIONS, 1996, 678 (02) :227-236
[5]   AN HPLC METHOD FOR THE DETERMINATION OF GRANISETRON IN GUINEA-PIG PLASMA [J].
CAPACIO, BR ;
BYERS, CE ;
JACKSON, TK ;
MATTHEWS, RL .
JOURNAL OF ANALYTICAL TOXICOLOGY, 1993, 17 (03) :151-155
[6]   Practical implications of some recent studies in electrospray ionization fundamentals [J].
Cech, NB ;
Enke, CG .
MASS SPECTROMETRY REVIEWS, 2001, 20 (06) :362-387
[7]   EVALUATION OF THE BIOEQUIVALENCE OF TABLET AND CAPSULE FORMULATIONS OF GRANISETRON IN PATIENTS UNDERGOING CYTOTOXIC CHEMOTHERAPY FOR MALIGNANT DISEASE [J].
CUPISSOL, D ;
BRESSOLLE, F ;
ADENIS, L ;
CARMICHAEL, J ;
BESSELL, E ;
ALLEN, A ;
WARGENAU, M ;
ROMAIN, D .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1993, 82 (12) :1281-1284
[8]   Cytochrome P-450 3A4: Regulation and role in drug metabolism [J].
Guengrich, FP .
ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, 1999, 39 :1-17
[9]   Simultaneous measurement of blood and brain microdialysates of granisetron in rat by high-performance liquid chromatography with fluorescence detection [J].
Huang, C ;
Chen, KC ;
Chen, CF ;
Tsai, TH .
JOURNAL OF CHROMATOGRAPHY B, 1998, 716 (1-2) :251-255
[10]   Biliary excretion of granisetron by microdialysis coupled to HPLC with fluorescence detection [J].
Huang, CT ;
Chen, CF ;
Tsai, TH .
JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, 1999, 22 (18) :2815-2823