VALIDATION OF A PROCEDURE FOR DETERMINATION OF MEXIDOL IN THE SUPPOSITORIES

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DOI: https://doi.org/None
Issue: 
3
Year: 
2016

Yu.A. Polkovnikova, PhD Voronezh State University; 1, Universitetskaya Square, Voronezh 394006

A rectal mexidol formulation was designed based on the results of physicochemical, biopharmaceutical, and technological investigations. To quantify the content of mexidol in the suppositories, the author proposed its spectrophotometric determination in the UV region at a wavelength of 297±2 nm. The assay procedure for mexidol was validated in accordance with the FDA guidelines for validation of analytical procedures. The assay procedure developed for mexidol is characterized by specificity, adequate accuracy (RSD = 0.75%), and precision in all concentration ranges (RSD = 2.46%), and a linear relationship (correlation coefficient (R) = 0.9998). Thus, the procedure may be properly reproduced and appropriate for further application.
Keywords: 
mexidol
ultraviolet spectrophotometry
suppositories
validation
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