Validation of the Methods of Quantitative Analysis of Ascorbic Acid and Rutoside in Chewing Lozenges

Introduction. Chewable lozenges are a relatively new dosage form with advantages such as ease of use, high bioavailability of active ingredients and the ability to control dosage. The development of new compositions with vitamins and vitamin-like substances is an urgent task, for which it is neces-sary to have validated methods for analyzing their quality. For the composition of lozenges with ascorbic acid and rutoside, titrimetric methods and spectrophotometry have been proposed. The purpose of the work is to validate methods for the quantitative determination of ascorbic acid and rutoside in chewable lozenges intended for use as therapeutic and preventive vitamin products. Material and methods. The developed methods for the quantitative determination of ascorbic acid and rutoside in chewing lozenges were validated according to the following indicators: specificity, linearity, analytical range, accuracy and precision (repeatability and intra-laboratory precision) in ac-cordance with the requirements of the GPM.1.1.0012 "Validation of analytical methods" of the State Pharmacopoeia of the Russian Federation XV edi-tion. Results. Based on the conducted validation, it was confirmed that all applied methods meet the necessary acceptance criteria, which guarantees the reliability and accuracy of the results of quantitative determination of ascorbic acid and rutoside in chewable lozenges. Conclusions. As a result of the conducted research, it was found that the spectrophotometric determination of rutoside in chewing lozenges is opti-mally carried out at a wavelength of 360 nm; ascorbic acid by iodometry (basic) and iodometry (alternative). The obtained data will be used in the de-velopment of regulatory documentation for the vitamin product