A critical quality parameter in quantitative fused-core chromatography: The injection volume
| Autor: | Bart De Spiegeleer, Kathelijne Peremans, Christian Burvenich, Lieselotte Veryser, Jente Boonen, Matthias D'Hondt |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Critical quality method-attribute (CQA)
Analytical chemistry Special Issue: HPLC in pharmaceutical analysis Pharmaceutical Science Pharmacy Analytical Chemistry Fused core chemistry.chemical_compound Quality (physics) Drug Discovery Electrochemistry Spectroscopy Medicine(all) Chromatography Biochemistry Genetics and Molecular Biology(all) Chemistry Spilanthol lcsh:RM1-950 Fused-core (pore-shell Halo®) HPLC Method development Solvent lcsh:Therapeutics. Pharmacology Injection volume Topical patch Superficially porous particles (SPP) Theoretical plate Methanol |
| Zdroj: | Journal of Pharmaceutical Analysis, Vol 3, Iss 5, Pp 330-334 (2013) Journal of Pharmaceutical Analysis |
| ISSN: | 2095-1779 |
| Popis: | 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 N-alkylamide 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 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 phenomenon which is confounded with the nature of the used sample solvent. From 2μL up to 100μL 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. Keywords: Spilanthol, Fused-core (pore-shell, Halo®) HPLC, Superficially porous particles (SPP), Injection volume, Topical patch, Critical quality method-attribute (CQA) |
| Databáze: | OpenAIRE |
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