HPLC法测定栀子中栀子苷含量的不确定度分析

Uncertainty Evaluation of Geniposide in Gardenia Fruit by HPLC

中药材及其制剂中有效成分的含量测定常采用高效液相色谱法,其测量结果的准确性与仪器的灵敏度、重复性、定量方法等因素有关。因此,分析影响测定结果不准确性的因素,可准确评价分析方法。本文采用HPLC法测定栀子苷的含量,并对影响分析结果的不确定因素进行分析、评价,最终给出测量结果的合成不确定度为0.58%,扩展不确定度为0.035%;栀子苷的含量测定结果为2.98%±0.035%。本方法可用于HPLC法测定药物含量的不确定分析。

The content of active components in Chinese medicinal materials and their preparations is often determined by HPLC.The accuracy of the measurement results is related to the sensitivity and repeatability of the instrument.Therefore,analysis of the factors affecting the inaccuracy of the determination results can accurately evaluate the analysis method.Through establishing HPLC determination mathematical model,the factors affecting the uncertainty were deduced,evaluated and calculated.The combined uncertainty was 0.058%,extended uncertainty was 0.035%,and the determined content of Baicalin was 2.98%±0.035%.The established analytical method is applicable to the uncertainty analysis of HPLC method in the determination of drugs.