Taevernier Lien, Wynendaele Evelien, D Hondt Matthias, De Spiegeleer Bart
Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
J Pharm Anal. 2015 Feb;5(1):27-32. doi: 10.1016/j.jpha.2014.06.001. Epub 2014 Jun 26.
The sample preparation of samples containing bovine serum albumin (BSA), as used in transdermal Franz diffusion cell (FDC) solutions, was evaluated using an analytical quality-by-design (QbD) approach. Traditional precipitation of BSA by adding an equal volume of organic solvent, often successfully used with conventional HPLC-PDA, was found insufficiently robust when novel fused-core HPLC and/or UPLC-MS methods were used. In this study, three factors (acetonitrile (%), formic acid (%) and boiling time (min)) were included in the experimental design to determine an optimal and more suitable sample treatment of BSA-containing FDC solutions. Using a QbD and Derringer desirability () approach, combining BSA loss, dilution factor and variability, we constructed an optimal working space with the edge of failure defined as <0.9. The design space is modelled and is confirmed to have an ACN range of 83±3% and FA content of 1±0.25%.
采用分析质量源于设计（QbD）方法，对用于经皮弗兰兹扩散池（FDC）溶液中含牛血清白蛋白（BSA）样品的制备进行了评估。通过添加等体积有机溶剂对BSA进行传统沉淀，这种方法常用于常规高效液相色谱 - 光电二极管阵列检测（HPLC - PDA），但在使用新型融合核高效液相色谱和/或超高效液相色谱 - 质谱（UPLC - MS）方法时，发现其稳健性不足。在本研究中，实验设计纳入了三个因素（乙腈（%）、甲酸（%）和煮沸时间（分钟）），以确定含BSA的FDC溶液的最佳且更合适的样品处理方法。使用QbD和德林格合意性（）方法，结合BSA损失、稀释因子和变异性，构建了一个最佳工作空间，将失败边缘定义为<0.9。对设计空间进行建模，证实乙腈范围为83±3%且甲酸含量为1±0.25%。
Zotero 插件
