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

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Abstract
As part of the method development, the injection volume as critical quality attribute in fast fused-core chromatography was evaluated. Spilanthol, a pharmaceutically interesting N-alkylamide currently under investigation in our laboratory, was chosen as model compound. Spilanthol was dissolved in both PBS and MeOH/H2O (70/30, v/v) and subsequently analysed using a fused-core hereby selecting five chromatographic characteristics (retention time, area, height, theoretical plates and symmetry factor) as responses. We demonstrated that the injection volume significantly influenced both the qualitative and quantitative performance of fused-core chromatography; a phenomena which is confounded with the nature of the used sample solvent. From 2 µL up to 100 µL injection volume with PBS as solvent, the symmetry factor decreased favorably with 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 with more than 60%, while the symmetry factor increased and the height decreased, both with 30%. The injection volume is thus a critical and often overlooked parameter in fused-core method description and validation.
Keywords
Fused-core (pore-shell, Spilanthol, Critical quality method-attribute (CQA), Topical patch, Halo®) HPLC, Superficially porous particles (SPP), Injection volume

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Chicago
Boonen, Jente, Matthias D’Hondt, Lieselotte Veryser, Kathelijne Peremans, Christian Burvenich, and Bart De Spiegeleer. 2013. “A Critical Quality Parameter in Quantitative Fused-core Chromatography: The Injection Volume.” Journal of Pharmaceutical Analysis 3 (5): 330–334.
APA
Boonen, Jente, D’Hondt, M., Veryser, L., Peremans, K., Burvenich, C., & De Spiegeleer, B. (2013). A critical quality parameter in quantitative fused-core chromatography: the injection volume. JOURNAL OF PHARMACEUTICAL ANALYSIS, 3(5), 330–334.
Vancouver
1.
Boonen J, D’Hondt M, Veryser L, Peremans K, Burvenich C, De Spiegeleer B. A critical quality parameter in quantitative fused-core chromatography: the injection volume. JOURNAL OF PHARMACEUTICAL ANALYSIS. 2013;3(5):330–4.
MLA
Boonen, Jente, Matthias D’Hondt, Lieselotte Veryser, et al. “A Critical Quality Parameter in Quantitative Fused-core Chromatography: The Injection Volume.” JOURNAL OF PHARMACEUTICAL ANALYSIS 3.5 (2013): 330–334. Print.
@article{3163737,
  abstract     = {As part of the method development, the injection volume as critical quality attribute in fast fused-core chromatography was evaluated. Spilanthol, a pharmaceutically interesting N-alkylamide currently under investigation in our laboratory, was chosen as model compound. Spilanthol was dissolved in both PBS and MeOH/H2O (70/30, v/v) and subsequently analysed using a fused-core hereby selecting five chromatographic characteristics (retention time, area, height, theoretical plates and symmetry factor) as responses. We demonstrated that the injection volume significantly influenced both the qualitative and quantitative performance of fused-core chromatography; a phenomena which is confounded with the nature of the used sample solvent. From 2 {\textmu}L up to 100 {\textmu}L injection volume with PBS as solvent, the symmetry factor decreased favorably with 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 with more than 60\%, while the symmetry factor increased and the height decreased, both with 30\%. The injection volume is thus a critical and often overlooked parameter in fused-core method description and validation.},
  author       = {Boonen, Jente and D'Hondt, Matthias and Veryser, Lieselotte and Peremans, Kathelijne and Burvenich, Christian and De Spiegeleer, Bart},
  issn         = {2095-1779},
  journal      = {JOURNAL OF PHARMACEUTICAL ANALYSIS},
  keyword      = {Fused-core (pore-shell,Spilanthol,Critical quality method-attribute (CQA),Topical patch,Halo{\textregistered}) HPLC,Superficially porous particles (SPP),Injection volume},
  language     = {eng},
  number       = {5},
  pages        = {330--334},
  title        = {A critical quality parameter in quantitative fused-core chromatography: the injection volume},
  url          = {http://dx.doi.org/10.1016/j.jpha.2013.02.002},
  volume       = {3},
  year         = {2013},
}

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