title: Development and validation of a sensitive and high-throughput LC-MS/MS method for the simultaneous determination of esomeprazole and naproxen in human plasma.
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.
authors.affiliation: Department of Pharmaceutical Analysis, Jawaharlal Nehru Technological University, Hyderabad, India.
authors.forename: Shanmugam
authors.initials: S
authors.lastname: Gopinath
authors.forename: Ramadass Satiesh
authors.initials: RS
authors.lastname: Kumar
authors.forename: Madhira Bhawani
authors.initials: MB
authors.lastname: Shankar
authors.forename: Palanisamy
authors.initials: P
authors.lastname: Danabal
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D064098:Esomeprazole / Q000097:blood* / Q000737:chemistry; D057166:High-Throughput Screening Assays; D006801:Humans; D016014:Linear Models; D009288:Naproxen / Q000097:blood* / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D052616:Solid Phase Extraction; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013696:Temperature
chemical_list: D009288:Naproxen; D064098:Esomeprazole