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Development and validation of a sensitive and high-throughput LC-MS/MS method for the simultaneous determination of esomeprazole and naproxen in human plasma.
- Source :
-
Biomedical chromatography : BMC [Biomed Chromatogr] 2013 Jul; Vol. 27 (7), pp. 894-9. Date of Electronic Publication: 2013 Mar 10. - Publication Year :
- 2013
-
Abstract
- A sensitive and high-throughput LC-MS/MS method has been developed and validated for the combined determination of esomeprazole and naproxen in human plasma with ibuprofen as internal standard. Solid-phase extraction was used to extract both analytes and internal standard from human plasma. Chromatographic separation was achieved in 4.0 min on XBridge C18 column using acetonitrile-25 mM ammonium formate (70:30, v/v) as mobile phase. Mass detection was achieved by ESI/MS/MS in negative ion mode, monitoring at m/z 344.19 → 194.12, 229.12 → 169.05 and 205.13 → 161.07 for esomeprazole, naproxen and IS, respectively. The calibration curves were linear from 3.00 to 700.02 ng/mL for esomeprazole and 0.50 to 150.08 ng/mL for naproxen. The intra- and inter-batch precision and accuracy across four quality control levels met established criteria of US Food and Drug Administration guidelines. The assay is suitable for measuring accurate esomeprazole and naproxen plasma concentrations in human bioequivalence study following combined administration.<br /> (Copyright © 2013 John Wiley & Sons, Ltd.)
- Subjects :
- Drug Stability
Esomeprazole chemistry
High-Throughput Screening Assays
Humans
Linear Models
Naproxen chemistry
Reproducibility of Results
Sensitivity and Specificity
Solid Phase Extraction
Temperature
Chromatography, Liquid methods
Esomeprazole blood
Naproxen blood
Tandem Mass Spectrometry methods
Subjects
Details
- Language :
- English
- ISSN :
- 1099-0801
- Volume :
- 27
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Biomedical chromatography : BMC
- Publication Type :
- Academic Journal
- Accession number :
- 23483550
- Full Text :
- https://doi.org/10.1002/bmc.2878