Validation of procedure for quantitative determination of flavonoid sum in ointment with peony extract of dry garden varieties

Every year, the need to develop new methods or optimize existing methods for standardization and quality control of drugs (PL) increases, as the requirements for the quality of raw materials and medicines, including PL with components of plant origin, increase. In order for analytical methods to guarantee reliable and accurate analysis results, a procedure for their validation is provided. Validation of the method of quantifying the sum of flavonoids in terms of rutin in ointments with peony extract of garden varieties of dry varieties was carried out by the method of mathematical statistics on indicators: specificity, linearity, correctness, precision (under conditions of repeatability), intralaboratory precision (reproducibility). In the course of determining the linearity of the technique, it was found that the graph of dependence has a linear character, the correlation coefficient is 0.9941. The specificity of the procedure was established by comparing the UV spectra of the standard sample (routine), ointment base and ointment base with the extract. It was found that the technique is specific in relation to the determined substance. The reduction percentage ranges from 95.4% to 101.5% and its average value was 98.5%, which indicates the correctness of the developed procedure. The calculated values of the coefficient of variation were 1.73% and 1.77%, they do not exceed the criteria for acceptability ± 5%, which indicates the precision of the technique under repeatability conditions. The calculated Fisher test value is less than the tabular value, hence the differences in results between the two analysts are statistically insignificant. Thus, the obtained intralaboratory precision values indicate the precision of the technique under reproducibility conditions.

validation, ointment, garden peony, dry extract, Tisol, flavonoids