title: Validation of HPLC method for the determination of polydatin in giant knotweed rhizome.
abstract: An HPLC method has been developed to determine polydatin in giant knotweed rhizome. In 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.
authors.affiliation: School of Traditional Chinese Materia Medica, National and Local Joint Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Shenyang Pharmaceutical University, Shenyang 110016, China.
authors.forename: Yu-Jiao
authors.initials: YJ
authors.lastname: Li
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.forename: Jing
authors.initials: J
authors.lastname: Ma
authors.forename: Qian-Qian
authors.initials: QQ
authors.lastname: Chen
authors.forename: Kai-Shun
authors.initials: KS
authors.lastname: Bi
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004355:Drug Stability; D045468:Fallopia japonica / Q000737:chemistry*; D005960:Glucosides / Q000032:analysis*; D010946:Plants, Medicinal / Q000737:chemistry*; D015203:Reproducibility of Results; D027343:Rhizome / Q000737:chemistry; D012680:Sensitivity and Specificity; D013267:Stilbenes / Q000032:analysis*
chemical_list: D005960:Glucosides; D013267:Stilbenes; C058229:polydatin