Molnár-Institute for Applied Chromatography, Schneeglöckchenstr.47, 10407 Berlin, Germany.
J Pharm Biomed Anal. 2011 Dec 15;56(5):874-9. doi: 10.1016/j.jpba.2011.04.015. Epub 2011 Apr 22.
The current article presents a novel approach to applying Quality by Design (QbD) principles to the development of high pressure reversed phase liquid chromatography (HPLC) methods. Four common critical parameters in HPLC--gradient time, temperature, pH of the aqueous eluent, and stationary phase--are evaluated within the Quality by Design framework by the means of computer modeling software and a column database, to a satisfactory degree. This work proposes the establishment of two mutually complimentary Design Spaces to fully depict a chromatographic method; one Column Design Space (CDS) and one Eluent Design Space (EDS) to describe the influence of the stationary phase and of the mobile phase on the separation selectivity, respectively. The merge of both Design Spaces into one is founded on the continuous nature of the mobile phase influence on retention and the great variety of the stationary phases available.
本文提出了一种将质量源于设计（QbD）原理应用于高压反相液相色谱（HPLC）方法开发的新方法。通过计算机建模软件和柱数据库，在质量源于设计框架内评估了 HPLC 中四个常见的关键参数-梯度时间、温度、水相洗脱液的 pH 值和固定相-在一定程度上达到了令人满意的效果。这项工作提出建立两个相互补充的设计空间，以充分描述色谱方法；一个是柱设计空间（CDS），另一个是洗脱液设计空间（EDS），分别描述固定相和流动相对分离选择性的影响。这两个设计空间的合并是基于流动相对保留的连续影响以及可用固定相的多样性。
