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Collaborative study of a GLC method for vitamin E

A J Sheppard, W D Hubbard

    Journal of Pharmaceutical Sciences
    |January 1, 1979
    PubMed
    Summary
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    A modified gas-liquid chromatography (GLC) method for vitamin E analysis was validated for the National Formulary (NF). The study confirmed the method

    Area of Science:

    • Analytical Chemistry
    • Pharmaceutical Analysis

    Background:

    • The official Association of Official Analytical Chemists (AOAC) method for vitamin E determination requires validation for National Formulary (NF) applications.
    • Existing methods may not fully address the diverse formulations and bulk materials specified by the NF.

    Purpose of the Study:

    • To modify and collaboratively study an existing gas-liquid chromatography (GLC) method for determining vitamin E content.
    • To ensure the modified method meets the stringent requirements of the National Formulary (NF).

    Main Methods:

    • Modification of the AOAC GLC method, including substitution of the internal standard from dotriacontane to hexadecyl hexadecanoate (cetyl palmitate).
    • Collaborative study involving 11 laboratories analyzing 11 diverse NF sample types (formulations and bulk materials).

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  • Statistical analysis of reproducibility and repeatability coefficients of variation.

    • Main Results:

    • Overall coefficients of variation for reproducibility and repeatability were 4.5% and 2.4%, respectively.
    • Excluding an outlier laboratory, these values improved to 3.4% and 1.6%.
    • Specific coefficients for alpha-tocopheryl acid succinate were 2.1% (reproducibility) and 1.5% (repeatability), all within the NF's 5% limit.

    Conclusions:

    • The modified GLC method is suitable for the accurate determination of vitamin E in NF materials.
    • The method demonstrates high precision and accuracy, meeting NF validation criteria.
    • This validated method supports quality control for vitamin E in pharmaceutical products.