Determination of tapentadol (Nucynta®) and N-desmethyltapentadol in authentic urine specimens by ultra-performance liquid chromatography-tandem mass spectrometry

J Anal Toxicol. 2010 Oct;34(8):450-7. doi: 10.1093/jat/34.8.450.

Abstract

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-of-flight mass spectrometer in lieu of suitable analytical reference standards. The presence of significant N-desmethyltapentadol glucuronide was demonstrated for the first time.

Publication types

  • Validation Study

MeSH terms

  • Analgesics / urine*
  • Chromatography, High Pressure Liquid
  • Humans
  • Pain Management / methods
  • Phenols / urine*
  • Receptors, Opioid, mu / antagonists & inhibitors*
  • Reproducibility of Results
  • Tandem Mass Spectrometry / methods*
  • Tapentadol

Substances

  • Analgesics
  • N-desmethyltapentadol
  • Phenols
  • Receptors, Opioid, mu
  • Tapentadol