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Validation of the HS-GC-FID method for the determination of ethanol residue in tablets

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Abstract

This paper describes the validation of a HS-GC-FID method (based on the Pharmacopeia’s method) for the determination of ethanol content in tablets. A general view of the procedure development/optimization process is presented. The main point of this study is the calculation of validation parameters. Selectivity of the method was determined. Linearity (r > 0.997) was observed in the range from 9.0 to 3,040 μg of ethanol per sample (because the mass of the tablets used was around 200 mg, this corresponds to 45–15,200 μg g−1). The method showed good recoveries (average 99.0%), and a relative standard deviation for repeatability and intermediate precision of 4.5% and 5.5% respectively. The limit of detection was calculated to be 3.0 μg of ethanol per sample (15 μg g−1). The uncertainty budget was done according to the "Guide to the Expression of Uncertainty in Measurement" (GUM)[1], and a relative expanded uncertainty was estimated as 4.8%.

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Authors and Affiliations

  1. Department of Analytical Chemistry, Chemical Faculty, Gdansk University of Technology, 11/12 Narutowicza Str., 80-952, Gdańsk, Poland

    Magdalena Michulec, Piotr Konieczka & Jacek Namieśnik

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  1. Magdalena Michulec
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  2. Piotr Konieczka
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  3. Jacek Namieśnik
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Correspondence to Piotr Konieczka.

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Michulec, M., Konieczka, P. & Namieśnik, J. Validation of the HS-GC-FID method for the determination of ethanol residue in tablets. Accred Qual Assur 12, 257–262 (2007). https://doi.org/10.1007/s00769-006-0252-3

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  • DOI: https://doi.org/10.1007/s00769-006-0252-3

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