A sensitive and high-throughput LC-MS/MS method for the quantification of pegylated-interferon-alpha2a in human serum using monolithic C18 solid phase extraction for enrichment

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Jun 15;877(18-19):1737-42. doi: 10.1016/j.jchromb.2009.04.033. Epub 2009 May 3.

Abstract

The analysis of pegylated-interferon-alpha(2a) in patient serum samples is of high interest for clinic research trials, as this therapeutic protein has become an important antiviral treatment. In this study, an LC-MS/MS method for the absolute quantification of pegylated-interferon-alpha(2a) in human serum was developed. The assay achieved a lower limit of quantification of 3.6 ng/mL (60 pM) with the use of a monolithic C(18) solid phase extraction to enrich the target protein. The linear range of the assay was defined up to 54 ng/mL to measure the typical clinical pegylated-interferon-alpha(2a) levels, and within this range, the precision and accuracy were found to be within +/-20%. The method was applied to a clinical study and found suitable for high-throughput analysis of pegylated-interferon-alpha(2a) in human serum. In addition, further investigations suggested the enrichment step may have general application to the sensitive analysis of other low molecular weight proteins.

MeSH terms

  • Antiviral Agents / blood*
  • Chromatography, Liquid / methods*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / blood*
  • Mass Spectrometry / methods*
  • Polyethylene Glycols
  • Recombinant Proteins
  • Sensitivity and Specificity

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • peginterferon alfa-2a