Robustness tests on the United States Pharmacopoeia XXVI HPLC assay for ginsenosides in Asian and American ginseng using an experimental design
文献类型：期刊论文
| 作者 | Li, YG; Liu, H ; Heyden, YV; Chen, M; Wang, ZT; Hu, ZB
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| 刊名 | ANALYTICA CHIMICA ACTA
 |
| 出版日期 | 2005-04-22 |
| 卷号 | 536期号:1-2页码:29-38 |
| 关键词 | robustness test ginsenosides Asian ginseng American ginseng fractional factorial design system suitability parameters |
| ISSN号 | 0003-2670 |
| DOI | 10.1016/j.aca.2004.12.071 |
| 文献子类 | Article |
| 英文摘要 | Ruggedness and robustness testing is applied prior to the transfer of a method to various laboratories. It is especially important for official methods that are widely and formally used. Ginsenosides (Rg(1), Re, Rf, Rb-1, Rg(2), Rc and Rd) occurring in Asian and American ginseng, were assayed using high -performance liquid chromatography (HPLC) methods issued by the United States Pharmacopoeia (USP XXVI and XXVII). They have a delicate system suitability to properly execute the method. A robustness test was carried out using an experimental design approach, in order to indicate the suitability of the method in a broad execution range. Seven factors are selected and examined by a fractional factorial design. Twelve responses, involving quantitation-related items, such as recovery of Rg(1) and Rb-1, and qualitative items, such as resolution (R-s), theoretical plate number (N), relative retention time (RRT) of two critical pairs, are measured. The calculated effects are both graphically and statistically interpreted to identify the significant factors. The robustness tests using fractional factorial design on the assay of ginsenosides provided an effective approach as part of a validation of the method on phytomedicines. It also indicated that methods with different selectivity, of which some are possibly unsuitable, could pass the existing system suitability limits. (c) 2004 Elsevier B.V. All rights reserved. |
| WOS关键词 | PERFORMANCE LIQUID-CHROMATOGRAPHY ; SYSTEM SUITABILITY TEST ; METHOD VALIDATION ; RUGGEDNESS TESTS ; PANAX-GINSENG ; STRATEGY |
| WOS研究方向 | Chemistry |
| 语种 | 英语 |
| WOS记录号 | WOS:000228673300005 |
| 出版者 | ELSEVIER SCIENCE BV |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/273882]  |
| 专题 | 新药研究国家重点实验室 中科院受体结构与功能重点实验室 |
| 通讯作者 | Li, YG |
| 作者单位 | 1.Chinese Acad Sci, Shanghai Inst Materia Medica, Ctr Drug Discovery & Design, State Key Lab Drug Res, Shanghai 201203, Peoples R China 2.Shanghai R&D Ctr Standardizat Tradit Chinese Med, Shanghai 201203, Peoples R China 3.Shanghai Univ Tradit Chinese Med, Inst Chinese Materia Medica, Shanghai 201203, Peoples R China 4.VUB, Dept Pharmaceut & Biomed Anal, B-1090 Brussels, Belgium |
| 推荐引用方式 GB/T 7714 | Li, YG,Liu, H,Heyden, YV,et al. Robustness tests on the United States Pharmacopoeia XXVI HPLC assay for ginsenosides in Asian and American ginseng using an experimental design[J]. ANALYTICA CHIMICA ACTA,2005,536(1-2):29-38. |
| APA | Li, YG,Liu, H,Heyden, YV,Chen, M,Wang, ZT,&Hu, ZB.(2005).Robustness tests on the United States Pharmacopoeia XXVI HPLC assay for ginsenosides in Asian and American ginseng using an experimental design.ANALYTICA CHIMICA ACTA,536(1-2),29-38. |
| MLA | Li, YG,et al."Robustness tests on the United States Pharmacopoeia XXVI HPLC assay for ginsenosides in Asian and American ginseng using an experimental design".ANALYTICA CHIMICA ACTA 536.1-2(2005):29-38. |
入库方式： OAI收割
来源：上海药物研究所
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