Application of a Reliable LC-MSMS Method for Determination of Rizatriptan in Healthy Subject Samples : Demonstration of Assay Reproducibility by Incurred Sample Reanalysis
Joint Authors
Shrivastav, Pranav S.
Patel, Dinesh S.
Patel, Mukesh C.
Patel, Bhavin N.
Sharma, Naveen
Sanyal, Mallika
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-12-10
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A reliable, rapid, and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of rizatriptan in human plasma using sumatriptan as internal standard (IS).
The analyte and IS were extracted from 300 μL human plasma via liquid-liquid extraction and the chromatography was achieved on Hypurity C18 (50 mm × 4.6 mm, 5 μm) column under isocratic conditions.
Detection of rizatriptan and IS was done by tandem mass spectrometry, operating in positive ionization and multiple-reaction monitoring mode.
The limit of detection and lower limit of quantitation of the method were 0.04 and 0.20 ng/mL, respectively, with a linear dynamic range of 0.20–60.0 ng/mL.
The intrabatch and interbatch precision (% CV) was ≤8.4% while the mean extraction recovery was >78% across quality control levels.
Bench top stability, freeze and thaw stability, processed sample stability, and long-term stability in plasma were evaluated at two quality control levels.
It was successfully applied to a bioequivalence study of 10 mg rizatriptan orally disintegrating tablet formulation in 40 and 32 healthy Indian male subjects under fasting and fed conditions, respectively.
The reproducibility in the measurement of study data was demonstrated by reanalysis of 254 incurred samples.
American Psychological Association (APA)
Patel, Dinesh S.& Sharma, Naveen& Patel, Mukesh C.& Patel, Bhavin N.& Shrivastav, Pranav S.& Sanyal, Mallika. 2012. Application of a Reliable LC-MSMS Method for Determination of Rizatriptan in Healthy Subject Samples : Demonstration of Assay Reproducibility by Incurred Sample Reanalysis. ISRN Chromatography،Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-496723
Modern Language Association (MLA)
Patel, Dinesh S.…[et al.]. Application of a Reliable LC-MSMS Method for Determination of Rizatriptan in Healthy Subject Samples : Demonstration of Assay Reproducibility by Incurred Sample Reanalysis. ISRN Chromatography No. 2012 (2012), pp.1-10.
https://search.emarefa.net/detail/BIM-496723
American Medical Association (AMA)
Patel, Dinesh S.& Sharma, Naveen& Patel, Mukesh C.& Patel, Bhavin N.& Shrivastav, Pranav S.& Sanyal, Mallika. Application of a Reliable LC-MSMS Method for Determination of Rizatriptan in Healthy Subject Samples : Demonstration of Assay Reproducibility by Incurred Sample Reanalysis. ISRN Chromatography. 2012. Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-496723
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-496723