Validation of Sedative Druganalysis Results

Abstract

Annotation. The article reveals validation studies of the method of quantitative analysis of high-performance
liquid chromatography of a complex and multicomponent original sedative drug produced in the Republic of
Uzbekistan. Criteria for repeatability, accuracy, precision, intermediate accuracy and correlation coefficients
for drug validation were determined. The analytical method for determining the number of tablets covered
with a film “Sedarem” from the proportion of valeric acids in the main active ingredients of the drug was
determined on the basis of the 5th series of the “Accuracy” indicator. The accuracy of valeric acid is judged
from at least 5 data obtained for each of the 3 levels lying within the analytical domain of the quantification
method. Comparing the results of determining the amount of valeric acid, it turns out that there is no
statistically significant difference between them, that the three time points for each series are mutually
compatible.
The analysis procedure for determining the amount of phenolic compounds in the preparation, when
comparing “Precision” with the results of determining the amount of phenolic compounds at different
intervals and on different days, which characterizes repetition and “intermediate precision,” it was found
that there is no statistical reliable difference between them, and three time points for each series are mutually
compatible. Study of drug linearity from flavanoid fraction was carried out in the range from 80 to 120% of
nominal value of analytical parameters.