1. Quantitative estimation of riluzole in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study.
- Author
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Chandu BR, Nama S, Kanala K, Challa BR, Shaik RP, and Khagga M
- Subjects
- Calibration, Excitatory Amino Acid Antagonists pharmacokinetics, Humans, Limit of Detection, Reference Standards, Reproducibility of Results, Riluzole pharmacokinetics, Therapeutic Equivalency, Chromatography, Liquid methods, Excitatory Amino Acid Antagonists blood, Riluzole blood, Spectrometry, Mass, Electrospray Ionization methods, Tandem Mass Spectrometry methods
- Abstract
A novel simple, sensitive, selective, and rapid high-performance liquid chromatography coupled with tandem mass spectrometry method was developed and validated for quantification of riluzole in human plasma. The chromatography was performed by using a Zorbax-SB-C18 (4.6 x 75 mm, 3.5 microm) column , isocratic mobile phase 0.1% formic acid/acetonitrile (10:90 v/v), and an isotope-labeled internal standard (IS), [(13)C,(15)N(2)]riluzole. The extraction of drug and internal standard was performed by liquid-liquid extraction and analyzed by MS in the multiple reaction monitoring (MRM) mode using the respective [M+H](+) ions, m/z 235.0/165.9 for riluzole and m/z 238.1/169.0 for the IS. The calibration curve was linear over the concentration range 0.5-500.0 ng/ml for riluzole in human plasma. The limit of quantification (LOQ) was demonstrated at 0.5 ng/ml. The within-batch and between-batch precision were 0.6-2.3% and 1.4-5.7%, and accuracy was 97.1-101.1% and 98.8-101.2% for riluzole respectively. Drug and IS were eluted within 3.0 min. The validated method was successfully applied in a bioequivalence study of riluzole in human plasma.
- Published
- 2010
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