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N-alkylamide profiling of Achillea ptarmica and Achillea millefolium extracts by liquid and gas chromatography–mass spectrometry

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Journal of Pharmaceutical Analysis 2017年第1期7卷 34-47页

作者： lieselotte veryser Lien Taevernier Evelien Wynendaele Yannick Verheust Ann Dumoulin Bart De Spiegeleer Drug Quality and Registration (DruQuaR) group Faculty of Pharmaceutical Sciences Ghent University Ottergemsesteenweg 460 B-9000 Ghent Belgium LIWET Department of Industrial Biological Sciences Ghent University Campus Kortrijk Graaf Karel de Goedelaan 5 B-8500 Kortrijk Belgium

Achillea millefolium and Achillea ptarmica are both plants belonging to the Asteracea family and are traditionally used for their medicinal properties. It has already been shown that some N-alkylamides(NAAs)are responsible for these pharmacological actions. Therefore, in the present study, the NAA content of the two plants was analytically characterised. Different extracts were prepared from the roots, the leaves, the stems and the flowers. The structures of NAAs have been assigned in ethanolic extracts of Achillea millefolium and Achillea ptarmica using high performance liquid chromatography – electrospray ionisation – mass spectrometry(HPLC–ESI–MS) and gas chromatography – electron impact – mass spectrometry(GC–EI–MS). Using both analytical techniques, the structures of 14 and 15 NAAs have been assigned in Achillea ptarmica and Achillea millefolium, respectively. Structures of two new NAAs, previously never observed in Achillea ptarmica,were assigned: deca-2E,6Z,8E-trienoic acid 2-methylbutylamide(homospilanthol) or a related isomeric compound and deca-2E,4E-dienoic acid N-methyl isobutylamide. The structure of homospilanthol or a related isomeric compound was also assigned in Achillea millefolium for the first time.

关键词： N-alkylamides Achillea millefolium Achillea ptarmica HPLC–ESI–MS GC–EI–MS

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Risk evaluation of impurities in topical excipients:The acetol case

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Journal of Pharmaceutical Analysis 2014年第5期4卷 303-315页

作者： Jente Boonen lieselotte veryser Lien Taevernier Nathalie Roche Kathelijne Peremans Christian Burvenich Bart De Spiegeleer Drug Quality and Registration (DruQuaR) Group Faculty of Pharmaceutical SciencesGhent UniversityHarelbekestraat 729000 GhentBelgium Department of Plastic and Reconstructive Surgery University Hospital GhentDe Pintelaan 185B-9000 GhentBelgium Department of Veterinary Medical Imaging and Small Animal Orthopaedics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium Department of Comparative Physiology and Biometrics Faculty of Veterinary MedicineGhent UniversitySalisburylaan 133B-9820 MerelbekeBelgium

Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the evaluation of its health risk after dermal exposure. 〈br〉 An ex-vivo in-vitro permeation study using human skin in a Franz Diffusion Cell set-up and GC as quantification methodology showed a significant skin penetration with an overall Kp value of 1.82 ？ 10 ？ 3 cm/h. Using these data, limit specifications after application of a dermal pharmaceutical product were estimated. Based on the TTC approach of Cramer class I substances, i.e. 1800 mg/（day？person）, the toxicity-qualified specification limits of acetol in topical excipients were calculated to be 90 mg/mL and 180 mg/mL for propylene glycol and glycerol, respectively.

关键词： Acetol Impurity Excipients Transdermal penetration Specification limits

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

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Journal of Pharmaceutical Analysis 2013年第5期3卷 330-334页

作者： Jente Boonen Matthias D’hondt lieselotte veryser Kathelijne Peremans Christian Burvenich Bart De Spiegeleer Drug Quality and Registration (DruQuaR) Group Faculty of Pharmaceutical Sciences Ghent University Department of Veterinary Medical Imaging and Small Animal Orthopaedics Faculty of Veterinary Medicine Ghent University Department of Comparative Physiology and Biometrics Faculty of Veterinary Medicine Ghent University

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/H20 （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 2 ~tL up to 100 laL 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： Spilanthol Fused-core (pore-shell,Halo) HPLC Superficially porousparticles (SPP) Injection volume ToPical patch Critical quality method-attribute (CQA)

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