VALIDATION OF THE METHOD FOR DETERMINING IODIDE IONS IN SOLUTIONS BY CAPILLARY ELECTROPHORESIS

Abstract

Introduction. The article is devoted to the validation of the analytical method for the
determination of iodide ions in solutions by capillary electrophoresis. This concept represents the entire
part of analytical chemistry, especially in the field of drug quality control, where the sensitivity and
specificity of the method are of crucial importance. The relevance of the study is due to the need for
accurate and reliable quantitative analysis of iodide ions in solution, including dosage forms, and complies
with international requirements (ICH Q2 (R1)) for the validation of analytical procedures. The objective
of this validation was to determine the validation characteristics of the method for determining iodide ions
in solutions by capillary electrophoresis.
Results and discussion. The article describes in detail the validation parameters: accuracy,
repeatability, limit of quantification, linearity and working range, which increases the practical value of
the validation results of this method. It was established that the limit of quantitative determination is 2.6
mg/l, the working range of the method is in the range from 2.6 mg/l to 240 mg/l, the correlation
coefficient is 0.9999. Conclusion. The work uses international ICH standards and internal company
procedures. Linearity is observed for the entire studied range from 0 to 200 mg/l. High sensitivity of the
method (2.6 mg/l) and linearity (R2 = 0.9999) are proven. The method fully meets its purpose, is
successfully used in the analysis of medicinal preparations, and the possibility of replacing potentiometric
titration with a more accurate method has been demonstrated. The methodology has practical significance
in the context of quality control.