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A critical quality parameter in quantitative fused-core chromatography: The injection volume

查看全文 作　　者：Jente [1]Boonen;Matthias D’[1]hondt;Lieselotte [1]Veryser;Kathelijne [2]Peremans;Christian [3]Burvenich;Bart De [1]Spiegeleer 高影响力作者 机构地区：[1]Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University;[2]Department of Veterinary Medical Imaging and Small Animal Orthopaedics, Faculty of Veterinary Medicine, Ghent University;[3]Department of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University高影响力机构 出　　处：《Journal of Pharmaceutical Analysis》索引2013年第3卷第5期,共5页高影响力期刊 基　　金：funded by the 'Institute for the Promotion of Innovation through Science and Technology in Flanders (IWT-Vlaanderen)’’ to Jente Boonen(No.091257) and to Matthias D’Hondt(No.101529) 摘　　要：As part of the method development,the injection volume as a critical quality attribute in fast fused-core chromatography was evaluated.Spilanthol,a pharmaceutically interesting Nalkylamide currently under investigation in our laboratory,was chosen as the model compound.Spilanthol was dissolved in both PBS and MeOH/H2O(70/30,v/v)and subsequently analyzed using a fused-core system hereby selecting fve chromatographic characteristics(retention time,area,height,theoretical plates and symmetry factor)as responses.We demonstrated that the injection volume signifcantly influenced both the qualitative and quantitative performance of fused-core chromatography,a phenomenon which is confounded with the nature of the used sample solvent.From 2 mL up to 100 mL injection volume with PBS as solvent,the symmetry factor decreased favorably by 20%.Moreover,the theoretical plates and the quantitative parameters(area and height)increased up to 30%.On the contrary,in this injection volume range,the theoretical plates for the methanol-based samples decreased by more than 60%,while the symmetry factor increased and the height decreased,both by 30%.The injection volume is thus a critical and often overlooked parameter in fused-core method description and validation. 关 键 词：色谱特性 注射量 质量参数 理论塔板数 模型化合物 进样量 质量属性 烷基酰胺
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