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LC-UV/MS quality analytics of paediatric artemether formulations

Author
Organization
Abstract
A highly selective and stability-indicating HPLC-method, combined with appropriate sample preparation steps, is developed for β-artemether assay and profiling of related impurities, including possible degradants, in a complex powder for oral suspension. Following HPLC conditions allowed the required selectivity: a Prevail organic acid (OA) column (250 mm×4.6 mm, 5 μm), flow rate set at 1.5 mL/min combined with a linear gradient (where A=25 mM phosphate buffer (pH 2.5), and B=acetonitrile) from 30% to 75% B in a runtime of 60 min. Quantitative UV-detection was performed at 210 nm. Acetonitrile was applied as extraction solvent for sample preparation. Using acetonitrile–water mixtures as extraction solvent, a compartmental behaviour by a non-solving excipient-bound fraction and an artemether-solubilising free fraction of solvent was demonstrated, making a mobile phase based extraction not a good choice. Method validation showed that the developed HPLC-method is considered to be suitable for its intended regulatory stability-quality characterisation of β-artemether paediatric formulations. Furthermore, LC–MS on references as well as on stability samples was performed allowing identity confirmation of the β-artemether related impurities. MS-fragmentation scheme of β-artemether and its related substances is proposed, explaining the m/z values of the in-source fragments obtained.
Keywords
Sample preparation, Paediatric formulations, Polar embedded organic acid column, Related impurities and degradation compounds, Artemisinin trioxane derivatives, MS-fragmentation

Citation

Please use this url to cite or link to this publication:

MLA
Vandercruyssen, Kirsten et al. “LC-UV/MS Quality Analytics of Paediatric Artemether Formulations.” JOURNAL OF PHARMACEUTICAL ANALYSIS 4.1 (2014): 37–52. Print.
APA
Vandercruyssen, K., D’Hondt, M., Vergote, V., Jansen, H., Burvenich, C., & De Spiegeleer, B. (2014). LC-UV/MS quality analytics of paediatric artemether formulations. JOURNAL OF PHARMACEUTICAL ANALYSIS, 4(1), 37–52.
Chicago author-date
Vandercruyssen, Kirsten, Matthias D’Hondt, Valentijn Vergote, Herwig Jansen, Christian Burvenich, and Bart De Spiegeleer. 2014. “LC-UV/MS Quality Analytics of Paediatric Artemether Formulations.” Journal of Pharmaceutical Analysis 4 (1): 37–52.
Chicago author-date (all authors)
Vandercruyssen, Kirsten, Matthias D’Hondt, Valentijn Vergote, Herwig Jansen, Christian Burvenich, and Bart De Spiegeleer. 2014. “LC-UV/MS Quality Analytics of Paediatric Artemether Formulations.” Journal of Pharmaceutical Analysis 4 (1): 37–52.
Vancouver
1.
Vandercruyssen K, D’Hondt M, Vergote V, Jansen H, Burvenich C, De Spiegeleer B. LC-UV/MS quality analytics of paediatric artemether formulations. JOURNAL OF PHARMACEUTICAL ANALYSIS. 2014;4(1):37–52.
IEEE
[1]
K. Vandercruyssen, M. D’Hondt, V. Vergote, H. Jansen, C. Burvenich, and B. De Spiegeleer, “LC-UV/MS quality analytics of paediatric artemether formulations,” JOURNAL OF PHARMACEUTICAL ANALYSIS, vol. 4, no. 1, pp. 37–52, 2014.
@article{4126944,
  abstract     = {A highly selective and stability-indicating HPLC-method, combined with appropriate sample preparation steps, is developed for β-artemether assay and profiling of related impurities, including possible degradants, in a complex powder for oral suspension. Following HPLC conditions allowed the required selectivity: a Prevail organic acid (OA) column (250 mm×4.6 mm, 5 μm), flow rate set at 1.5 mL/min combined with a linear gradient (where A=25 mM phosphate buffer (pH 2.5), and B=acetonitrile) from 30% to 75% B in a runtime of 60 min. Quantitative UV-detection was performed at 210 nm. Acetonitrile was applied as extraction solvent for sample preparation. Using acetonitrile–water mixtures as extraction solvent, a compartmental behaviour by a non-solving excipient-bound fraction and an artemether-solubilising free fraction of solvent was demonstrated, making a mobile phase based extraction not a good choice. Method validation showed that the developed HPLC-method is considered to be suitable for its intended regulatory stability-quality characterisation of β-artemether paediatric formulations. Furthermore, LC–MS on references as well as on stability samples was performed allowing identity confirmation of the β-artemether related impurities. MS-fragmentation scheme of β-artemether and its related substances is proposed, explaining the m/z values of the in-source fragments obtained.},
  author       = {Vandercruyssen, Kirsten and D'Hondt, Matthias and Vergote, Valentijn and Jansen, Herwig and Burvenich, Christian and De Spiegeleer, Bart},
  issn         = {2095-1779},
  journal      = {JOURNAL OF PHARMACEUTICAL ANALYSIS},
  keywords     = {Sample preparation,Paediatric formulations,Polar embedded organic acid column,Related impurities and degradation compounds,Artemisinin trioxane derivatives,MS-fragmentation},
  language     = {eng},
  number       = {1},
  pages        = {37--52},
  title        = {LC-UV/MS quality analytics of paediatric artemether formulations},
  url          = {http://dx.doi.org/10.1016/j.jpha.2013.03.006},
  volume       = {4},
  year         = {2014},
}

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