A critical quality parameter in quantitative fused-core chromatography: The injection volume
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...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2013-10-01
|
| Series: | Journal of Pharmaceutical Analysis |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2095177913000130 |
| _version_ | 1818663623864614912 |
|---|---|
| author | Jente Boonen Matthias Dâhondt Lieselotte Veryser Kathelijne Peremans Christian Burvenich Bart De Spiegeleer |
| author_facet | Jente Boonen Matthias Dâhondt Lieselotte Veryser Kathelijne Peremans Christian Burvenich Bart De Spiegeleer |
| author_sort | Jente Boonen |
| collection | DOAJ |
| description | 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) |
| first_indexed | 2024-12-17T05:19:48Z |
| format | Article |
| id | doaj.art-683ecc8850c64ec99f34136eb0469b40 |
| institution | Directory Open Access Journal |
| issn | 2095-1779 |
| language | English |
| last_indexed | 2024-12-17T05:19:48Z |
| publishDate | 2013-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Pharmaceutical Analysis |
| spelling | doaj.art-683ecc8850c64ec99f34136eb0469b402022-12-21T22:02:00ZengElsevierJournal of Pharmaceutical Analysis2095-17792013-10-0135330334A critical quality parameter in quantitative fused-core chromatography: The injection volumeJente Boonen0Matthias Dâhondt1Lieselotte Veryser2Kathelijne Peremans3Christian Burvenich4Bart De Spiegeleer5Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, BelgiumDrug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, BelgiumDrug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, BelgiumDepartment of Veterinary Medical Imaging and Small Animal Orthopaedics, Faculty of Veterinary Medicine, Ghent University, Salisburylaan 133, B-9820 Merelbeke, BelgiumDepartment of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Salisburylaan 133, B-9820 Merelbeke, BelgiumDrug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium; Corresponding author. Tel.: +32 9 264 81 00; fax: +32 9 264 81 93.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)http://www.sciencedirect.com/science/article/pii/S2095177913000130 |
| spellingShingle | Jente Boonen Matthias Dâhondt Lieselotte Veryser Kathelijne Peremans Christian Burvenich Bart De Spiegeleer A critical quality parameter in quantitative fused-core chromatography: The injection volume Journal of Pharmaceutical Analysis |
| title | A critical quality parameter in quantitative fused-core chromatography: The injection volume |
| title_full | A critical quality parameter in quantitative fused-core chromatography: The injection volume |
| title_fullStr | A critical quality parameter in quantitative fused-core chromatography: The injection volume |
| title_full_unstemmed | A critical quality parameter in quantitative fused-core chromatography: The injection volume |
| title_short | A critical quality parameter in quantitative fused-core chromatography: The injection volume |
| title_sort | critical quality parameter in quantitative fused core chromatography the injection volume |
| url | http://www.sciencedirect.com/science/article/pii/S2095177913000130 |
| work_keys_str_mv | AT jenteboonen acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT matthiasdahondt acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT lieselotteveryser acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT kathelijneperemans acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT christianburvenich acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT bartdespiegeleer acriticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT jenteboonen criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT matthiasdahondt criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT lieselotteveryser criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT kathelijneperemans criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT christianburvenich criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume AT bartdespiegeleer criticalqualityparameterinquantitativefusedcorechromatographytheinjectionvolume |