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Interlaboratory study of analysis of phenoxymethylpenicillin by liquid chromatography

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Summary

A liquid chromatography method for analysis of phenoxymethylpenicillin has been examined in a collaborative study involving 6 laboratories. The method comprised an isocratic part, which is used in the assay. When the isocratic part is combined with gradient elution, the method is suitable for purity control. Five samples of phenoxymethylpenicillin (potassium salts and acid) were analysed. The main component, the most important side product 4-hydroxyphenoxymethyl-penicillin and other impurities were determined. An analysis of variance proved the absence of consistent laboratory bias. Laboratory-sample interaction was not significant. Estimates of the repeatability and reproducibility of the method, expressed as standard deviations (SD) of the result of the determination of phenoxymethylpenicillin, were 0.50 and 0.63 respectively.

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References

  1. Zhu Yongxin, E. Merken, M. P. Arevalo, E. Porqueras, E. Roets, J. Hoogmartens, Eur J. Pharm. Sci, in press.

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Authors and Affiliations

  1. Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, K. U. Leuven, Van Evenstraat 4, 3000, Leuven, Belgium

    Zhu Yongxin, E. Roets & J. Hoogmartens

  2. Hoechst Marion Roussel, Frankfurt/Main, Germany

    B. Trippen & Ch. -P. Christiansen

  3. Centro Nacional de Farmacobiologia, Madrid, Spain

    M. P. Arevalo & E. Porqueras

  4. Biochemie, Kundl, Austria

    B. Maichel & P. Inama

  5. Gist-Brocades AB, Strangnes, Sweden

    S. Söderholm

  6. European Pharmacopoeia, Strasbourg, France

    J. H. McB Miller & J. M. Spieser

Authors
  1. Zhu Yongxin
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  2. E. Roets
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  3. B. Trippen
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  4. Ch. -P. Christiansen
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  5. M. P. Arevalo
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  6. E. Porqueras
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  7. B. Maichel
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  8. P. Inama
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  9. S. Söderholm
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  10. J. H. McB Miller
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  11. J. M. Spieser
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  12. J. Hoogmartens
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Yongxin, Z., Roets, E., Trippen, B. et al. Interlaboratory study of analysis of phenoxymethylpenicillin by liquid chromatography. Chromatographia 47, 152–156 (1998). https://doi.org/10.1007/BF02466574

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  • DOI: https://doi.org/10.1007/BF02466574

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