Centre Universitaire Régional d'Interface, Université Sidi Mohamed Ben Abdellah, BP 2626, route d'Imouzzer, Fes Morocco; Laboratoire de Chimie Organique Appliquée, Faculté des Sciences et Techniques, BP 2202, route d'Imouzzer, Fes Morocco.
Laboratoire de Chimie Organique Appliquée, Faculté des Sciences et Techniques, BP 2202, route d'Imouzzer, Fes Morocco.
Anal Chim Acta. 2014 Jan 31;810:39-42. doi: 10.1016/j.aca.2013.11.037. Epub 2013 Nov 23.
Varlet et al. recently proposed a headspace-gas chromatography-mass spectrometry (HS-GC-MS) method applicable for the routine determination of CO2 in gaseous biologic matrices. This developed bioanalytical method was fully validated according to the SFSTP 1997 guidelines using the accuracy profile as a graphical decision-making tool.In this letter, we discuss the validity of HS-GC-MS method based on the newest SFSTP guideline. In particular, we demonstrate by the estimation of the β-expectation tolerance interval that the error total exceeds the acceptance limits (30%) for the second concentration level (0.5μmol mL(-1) vial HS). Furthermore, we show through the risk profile that the probability to have future results inside the ±30% acceptance limits is smaller than 95%.
瓦莱等人最近提出了一种顶空气相色谱-质谱联用(HS-GC-MS)方法,适用于常规测定气态生物基质中的 CO2。该生物分析方法是根据 SFSTP 1997 指南进行全面验证的,使用准确度概况作为图形决策工具。在这封信中,我们根据最新的 SFSTP 指南讨论了 HS-GC-MS 方法的有效性。特别是,我们通过β-期望容忍区间的估计表明,第二浓度水平(0.5μmol mL(-1)小瓶 HS)的总误差超过了可接受限(30%)。此外,我们通过风险概况表明,未来结果在±30%可接受限内的概率小于 95%。