Development and validation of a method for quantitative determination of dosage oral spray Sanguirithrin by UV spectrophotometry

As part of the “Strategy for the Control of Antimicrobial Therapy in Russia”, a dosed oral spray with a herbal component of domestic origin, Sanguirithrin, was developed at the Department of Pharmaceutical Technology. A key aspect of drug quality control is the quantitative determination of the active substance in the spray. For this purpose, a method for the spectrophotometric determination of Sanguirithrin in the UV spectrum was created and validated. The tested spray sample included Sanguirithrin, glycerin, PEG-400, poloxamer 407, and hydroxyethyl cellulose. Quantitative determination was carried out using a spectrophotometer, validating the method in accordance with a standard sample. Statistical processing of the results was carried out according to the established requirements. Optical density was measured by the spectrophotometer at 321 nm. The method has been validated for specificity, linearity, and precision. Specificity was confirmed by the coincidence of maxima (321 ± 2,0 nm) for the samples and the absence of the solvent influence. Linearity was assessed using 10 standard samples with concentrations of 2-20 mg/ml (10-125% of 20 mg/ml).