Validation of quantitative determination of original substance of dipeptide threonylthreonine

Abstract

Validation of the quantitative determination of the threonylthreonine substance was carried out in terms of specificity, linearity, correctness, precision, including repeatability and reproducibility. The linearity correlation coefficient of the method was 0.99998 in the range of 80–120 % of the standardized value. The calculated Student’s coefficients for the range 80, 100, 120 % are respectively equal to 1.32; 0.31; 0.55 and do not exceed the permissible limit values. The open rate was 100.07 %. The repeatability limit for one measurement group was – 0.20; for two – 0.366 in accordance with the eligibility criteria. The calculated Student’s (t = 1.34) and Fisher’s (F = 2.00) criteria for two groups of measurements did not exceed the permissible values. The developed technique for potentiometric titration of the threonylthreonine substance in a non-aqueous medium is valid.