title: Selection of reference standard during method development using the analytical hierarchy process.
abstract: Reference standard is critical for ensuring reliable and accurate method performance. One important issue is how to select the ideal one from the alternatives. Unlike the optimization of parameters, the criteria of the reference standard are always immeasurable. The aim of this paper is to recommend a quantitative approach for the selection of reference standard during method development based on the analytical hierarchy process (AHP) as a decision-making tool. Six alternative single reference standards were assessed in quantitative analysis of six phenolic acids from Salvia Miltiorrhiza and its preparations by using ultra-performance liquid chromatography. The AHP model simultaneously considered six criteria related to reference standard characteristics and method performance, containing feasibility to obtain, abundance in samples, chemical stability, accuracy, precision and robustness. The priority of each alternative was calculated using standard AHP analysis method. The results showed that protocatechuic aldehyde is the ideal reference standard, and rosmarinic acid is about 79.8% ability as the second choice. The determination results successfully verified the evaluation ability of this model. The AHP allowed us comprehensive considering the benefits and risks of the alternatives. It was an effective and practical tool for optimization of reference standards during method development.
authors: School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
authors: Wan-yang
authors: WY
authors: Sun
authors: Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors: Ling
authors: L
authors: Tong
authors: Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors: Dong-xiang
authors: DX
authors: Li
authors: China Pharmaceutical University, Nanjing 210009, China.
authors: Jing-yi
authors: JY
authors: Huang
authors: Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors: Shui-ping
authors: SP
authors: Zhou
authors: Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors: Henry
authors: H
authors: Sun
authors: School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China. Electronic address: kaishunbi.syphu@gmail.com.
authors: Kai-shun
authors: KS
authors: Bi
mesh_terms: D000447:Aldehydes / Q000737:chemistry; D002623:Chemistry Techniques, Analytical / Q000592:standards*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002934:Cinnamates / Q000737:chemistry; D053630:Depsides / Q000737:chemistry; D062385:Hydroxybenzoates / Q000737:chemistry; D012015:Reference Standards; D027561:Salvia miltiorrhiza / Q000737:chemistry; D000097123:Rosmarinic Acid
chemical_list: D000447:Aldehydes; D002934:Cinnamates; D053630:Depsides; D062385:Hydroxybenzoates; D000097123:Rosmarinic Acid; C017616:phenolic acid
keywords: Analytical hierarchy process; Method development; Reference standard; Salvia Miltiorrhiza; Ultra-performance liquid chromatography