4.7 Article

Improvement of the traceability of reference materials certified for purity: evaluation of a semi-preparative high-performance liquid chromatography approach

Journal

ANALYTICAL AND BIOANALYTICAL CHEMISTRY
Volume 394, Issue 8, Pages 2183-2192

Publisher

SPRINGER HEIDELBERG
DOI: 10.1007/s00216-009-2893-7

Keywords

Certified reference material; Purity; Semi-preparative HPLC

Funding

  1. UK Department for Innovation
  2. Universities and Skills

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A semi-preparative high-performance liquid chromatography process was evaluated as a tool to quantitatively determine the purity or percentage mass fraction content (% m/m) of organic compounds. The method is simple and does not require the identification and subsequent quantitation of organic-related structure impurities. A protocol was developed and tested on four reference materials certified for purity from 95% m/m to 99.3% m/m. Comparing the purity results of each certified reference material using the new approach with their respective certified values showed no significant analytical bias. Semi-preparative high-performance liquid chromatography has proved the potential to be a primary method directly traceable to mass with an uncertainty statement written down also in terms of mass with expanding uncertainty ranging from 0.8% to 1.3% m/m compared to 0.3 to 2.0% m/m for the certified purity values at the 95% confidence interval.

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