虎杖中虎杖苷HPLC含量测定的方法学验证研究(英文)

Validation of HPLC method for the determination of polydatin in giant knotweed rhizome

本文建立了测定虎杖中虎杖苷含量的RP-HPLC法,并对方法进行了系统的方法学验证,包括专属性、精密度、对照品线性、供试品线性、重复性、重现性、准确度、稳定性和耐用性试验。耐用性试验采用单因素循环法,考察了不同因素(如流速、柱温、提取时间等)的微小变化对虎杖苷测定结果的影响,并根据耐用性考察结果确定了方法的系统适用性参数限度。结果表明方法准确、可靠,耐用性良好。

An HPLC method has been developed to determine potyaaun m glare order to systematically validate the method, specificity, precision, linearity of reference solution and test solution, repeatability, reproducibility, accuracy, stability and robustness were measured. In the robustness test, a one- variable-at-a-time procedure was applied to evaluate the influence of slight variations in method factors, including the flow rate, the column temperature, the extraction time, and etc., on the assay result of polydatin. No significant differences were found when the process parameters changed during the experimental domain. And system suitability test limits were defined based on the robustness test. Results showed that the developed method was accurate, reproducible and robust.