Evaluation of uncertainty of measurement from method validation data: an application to the simultaneous determination of retinol and alpha-tocopherol in human serum by HPLC

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Apr 15;877(11-12):1209-15. doi: 10.1016/j.jchromb.2009.02.063. Epub 2009 Mar 5.

Abstract

An isocratic RP-HPLC method for the determination of retinol and alpha-tocopherol in serum, with fluorescence and UV/VIS detection, respectively, was developed and validated according to international guidelines. Detection (retinol 0.015 mg/L, alpha-tocopherol 0.29 mg/L) and quantification (retinol 0.05 mg/L, alpha-tocopherol 0.95 mg/L) limits were determined. Repeatability was <3.3% and <2.9% and intermediate precision was <4.6% and <3.2%, for retinol and alpha-tocopherol, respectively. Certified reference materials were utilised to assess bias and guarantee traceability to SI units. Expanded uncertainties (retinol 8.9%; alpha-tocopherol 7.9%), estimated according to the EURACHEM/CITAC guide from method validation data, satisfied fit-for-purpose requirements based on biological variability.

Publication types

  • Research Support, Non-U.S. Gov't
  • Twin Study

MeSH terms

  • Adult
  • Aged
  • Algorithms
  • Alzheimer Disease / blood
  • Calibration
  • Chromatography, High Pressure Liquid
  • Guidelines as Topic
  • Humans
  • Indicators and Reagents
  • Male
  • Occupational Exposure / adverse effects
  • Quality Control
  • Reference Standards
  • Reproducibility of Results
  • Spectrometry, Fluorescence
  • Spectrophotometry, Ultraviolet
  • Vitamin A / blood*
  • Vitamins / blood*
  • alpha-Tocopherol / blood*

Substances

  • Indicators and Reagents
  • Vitamins
  • Vitamin A
  • alpha-Tocopherol