高效液相色谱仪自动进样器校准方法及不确定度评定

HPLC Auto-Sampler Calibration Methods and Uncertainty Evaluation

建立高效液相色谱仪自动进样器的校准方法,并对其测量不确定度进行评定。参考欧洲医药管理局《质量控制文件》提供的方法对液相色谱仪自动进样器的进样体积误差、进样残留和进样重复性建立校准方法,经评定得进样体积误差的相对扩展不确定度为1.8%。高效液相色谱仪自动进样器校准方法及不确定度评定方法的建立,为高效液相色谱仪自动进样器的校准提供依据。

HPLC auto-sampler calibration method was established and its measurement uncertainty was evaluated. The method of HPLC auto-sampler injection volume error, injection build residual, and repeatability calibration method was established through the reference of the european medicines authority Quality Control Document, and the error injection volume relative expanded uncertainty degree was calculated of 1.8%. The establishment calibration methods and uncertainty evaluation provided the basis for calibration of HPLC auto-sampler.