Validation of the liquid chromatographic method for the determination of Methytestosterone in the food of animal origin.

Author: Nana Skhirtladze
Co-authors: Nana Skhirtladze
Keywords: Methytestosterone, Validation, The accuracy of the methodology, the full compliance of the method with the Guidance for Industry Bioanalytical Method Validation
Annotation:

A sensitive, repeatable, accurate, and efficient liquid chromatographic method for the quantitative determination of methytestosterone in the food of animal origin has been developed; The detection minimum of the method is 0.5 ng/ml, and the specific wavelength is 250.0 nm; The variation coefficient for the specificity of the obtained results is 0.02 for one working day, 0.03 for one working week, which indicates the compliance of the method specificity with the criteria set for the analytical methods (CV≤2%) The values of the results obtained in determining the accuracy are close to each other; the Variation coefficient of 6 parallel definitions is 0.02 for N8 caliber solution, 0.01 for N7 caliber solution, and 0.01 for N6 caliber solution; The results indicate the compliance of the selected method with the requirements for analytical methods (<2%); The methytestosterone’s calibration schedule is linear in the following ranges: 0.5 - 5.0 ng/ml, 5.0 - 50.0 ng/ml, 50.0 - 500.0 ng/ml and it is acceptable as long as the correlation coefficients are 0.999, 0.999 and 0.999, respectively; The accuracy of the methodology is 1.31% (criterion is <2%); The preparation of the samples is satisfactory because the obtained coefficients of extraction for all matrices are > 0.6; The results obtained from the measurement uncertainty confirm the compliance of the selected method with the requirements for analytical methods. Thus, as a result of the validation of the liquid chromatographic method developed for the quantitative determination of methytestosterone in the food of animal origin revealed the full compliance of the method with the Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001, according to the following validation characteristics: specificity, accuracy, correctness, and linearity.

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ცხოველური წარმოშობის საკვებ პროდუქტში მეთილტესტოსტერონის განსაზღვრის სითხოვანი ქრომატოგრაფიული მეთოდის ვალიდაცია [ka]