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The aim of the work is to develop and validate the method of quantitative determination of azelaic for treating acne. To determine the AA content in the drug the reversed phase HPLC has been proposed. Specificity of the method was confirmed by chromatograms of placebo and AA. To determine such validation value as precision of the method the AA working standard solution was chromatographed; according to the data obtained the mean value of the content of AA found in percent was calculated. To check accuracy of the results of the method the standard addition method was used. Reproducibility of the method was also checked. Robustness of the method was investigated within changes in the composition of the mobile phase, pH value of the mobile phase, the column temperature and the mobile phase rate according to the requirements of the State Pharmacopoeia of Ukraine. The method of quantitative determination of AA in a gel according to such indicators as specificity, linearity, precision, accuracy, reproducibility, stability and robustness can be considered valid.

Quantitative Determination of Azelaic Acid in “Propolis” Gel with the Propolis Phenolic Hydrophobic Drug for Treating Acne