Journal Article

Determination of Tapentadol (Nucynta<sup>®</sup>) and <i>N</i>-Desmethyltapentadol in Authentic Urine Specimens by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry

James A. Bourland, Ayodele A. Collins, Scot A. Chester, Sumankalai Ramachandran and Ronald C. Backer

in Journal of Analytical Toxicology

Volume 34, issue 8, pages 450-457
Published in print October 2010 | ISSN: 0146-4760
Published online October 2010 | e-ISSN: 1945-2403 | DOI:
Determination of Tapentadol (Nucynta®) and N-Desmethyltapentadol in Authentic Urine Specimens by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry

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Urine specimens from pain management patients dosed with Nucynta (Tapentadol) were confirmed for the presence of tapentadol and N-desmethyltapentadol using ultra-performance liquid chromatography-tandem mass spectrometry to minimize sample preparation and urine volume requirements. The linearity of the method for both tapentadol and N-desmethyltapentadol demonstrated correlation coefficients (R2) above 0.99 and linear ranges from 50 to 500,000 ng/mL for tapentadol and 100 to 500,000 ng/mL for N-desmethyltapentadol. The intraday precision of the assay for both analytes ranged from 2.2 to 6.9% over three concentrations; the interday precision for both analytes ranged from 1.2 to 8.4%. The limits of quantitation were 50 and 100 ng/mL for tapentadol and N-desmethyltapentadol, respectively, and the upper limit of linearity for both analytes was determined to be 500,000 ng/mL. Urine samples were collected within 24 h of dosing with tapentadol and shipped overnight to the laboratory. Samples were hydrolyzed with acid prior to analysis to measure total (unconjugated and conjugated) tapentadol and N-desmethyltapentadol. Further investigation into characterization of metabolites was performed by using a hybrid quadrupole-time-off-light mass spectrometer in lieu of suitable analytical reference standards. The presence of significant N-desmethyltapentadol glucuronide was demonstrated for the first time.

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Subjects: Medical Toxicology ; Toxicology (Non-medical)

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