VALIDATION OF THE METHOD FOR DETERMINING THE CONCENTRATION OF IODIDE IONS IN DIFFERENT DOSAGE FORMS BY UV SPECTROPHOTOMETRY

Abstract

Abstract. This article is devoted to the validation of an analytical method for the determination of iodide ions in various dosage forms using UV spectrophotometry. This method is an important part of analytical chemistry and drug quality control systems, in which the sensitivity, specificity, and reproducibility of the method are crucial. The relevance of the study is determined by the need for accurate and reliable quantitative determination of iodide ions in pharmaceutical substances and finished drug products. Validation was conducted in accordance with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Q2(R1)/Q2(R2)). The aim of this study was to determine the validation characteristics of a method for the quantitative determination of iodide ions in dosage forms using UV spectrophotometry. Results and discussion. The following parameters were evaluated: specificity, linearity, working range, accuracy, repeatability, within-laboratory precision, and solution stability. The working range was found to be from 20 to 240 mg/L, and the correlation coefficient was 0.9998. The method demonstrated high sensitivity and compliance with international requirements. Conclusion. The results obtained confirm the linearity of the method across the studied range of iodide ion concentrations. High sensitivity and a high degree of linearity (R² = 0.9998) were demonstrated. The developed method is suitable for its intended purpose and can be successfully applied in the analysis of iodine-containing medicinal products. The method has practical significance for pharmaceutical quality control systems.