Validation of Sedative Druganalysis Results

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

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