title: Ruggedness and robustness of conversion factors in method of simultaneous determination of multi-components with single reference standard.
abstract: Single standard to determine multi-components (SSDMC) is a novel and rational method for quality control of botanical products and traditional Chinese medicines (TCMs). However, it is restricted to wide application due to unknown fluctuation in conversion factors when it is performed in different laboratories. To evaluate the fluctuations of conversion factors, we selected Salvia miltiorrhiza as an example to determine three components of tanshinones by SSDMC method. Then ruggedness and robustness test were adopted to comprehensively investigate three kinds of factors that may influence stability of conversion factors, which were related with environmental parametric variables, operational parametric variables and peak measurement parametric variables. Nested-factorial-design was used to perform ruggedness tests. One-variable-at-a-time (OVAT) procedure and Plackett-Burman (PB) design were both used in robustness test. The results showed that stability of conversion factors was principally related with accuracy of wavelength of UV detector, peak measurement parameters and concentration of standard solution. The acceptable range of conversion factors was obtained from robustness test. Our results showed that conversion factors were inevitable to change, but when key parameters were well controlled, the range of its fluctuation was acceptable and the SSDMC method could be used widely in different laboratories.
authors: Shanghai Research Center for Modernization of Traditional Chinese Medicine, National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
authors: Jin-Jun
authors: JJ
authors: Hou
authors: Wan-Ying
authors: WY
authors: Wu
authors: Juan
authors: J
authors: Da
authors: Shuai
authors: S
authors: Yao
authors: Hua-Li
authors: HL
authors: Long
authors: Zhou
authors: Z
authors: Yang
authors: Lu-Ying
authors: LY
authors: Cai
authors: Min
authors: M
authors: Yang
authors: Xuan
authors: X
authors: Liu
authors: Bao-Hong
authors: BH
authors: Jiang
authors: De-An
authors: DA
authors: Guo
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards*; D004365:Drugs, Chinese Herbal / Q000032:analysis*; D012015:Reference Standards; D027561:Salvia miltiorrhiza / Q000737:chemistry*
chemical_list: D004365:Drugs, Chinese Herbal