DEVELOPMENT AND VALIDATION OF THE PROCEDURE FOR QUANTIFICATION OF COMPOUND VMU-2012-05 (1-[2-(2-BENZOYLPHENOXY)ETHYL]-6-METHYLURACIL) IN TABLETS

Abstract

Aim. To develop a methodology for quantification of compound VMU-2012-05 (1-[2-(2-benzoylphenoxy)ethyl]-6methyluracil) in tablets.

Materials and methods. The method of capillary electrophoresis (CE) was used to develop and validate the procedure for the quantification of VMU-2012-05 (1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil) in the form of tablets. It is shown that if 10 mM sodium borate is used as the leading electrolyte with a pH of 11.0, it is possible to assure an analysis time of up to 6 minutes. The experiment parameters were as follows: quartz capillary (diameter 75 μm, WL/Lef = 60/50 cm), voltage +20 kV, temperature 25°C, detection at 256 nm, sample entry at 150 mbar × s.

Results. The validation assessment of the developed methodology for indicators specificity, analytical area, linearity, accuracy and precision indicates that the methodology is specific, and in terms of indicators, the analytical area and linearity meet the requirements of the GF XIII edition. In addition, it is shown that the technique yields results free of systematic error (the correctness of the technique), and the precision is at a sufficiently low level (RSD = 1,53%). Also, for the developed and validated methodology, the parameters of the system suitability for the parameters were determined by the number of theoretical plates of the VMU-2012-05 peak, the resolution of the VMU-2012-05 peak and the EOS signal and the VMU-2012-05 peak symmetry factor.

Conclusion. The developed rapid method of quantitative determination of VMU-2012-05 in tablets will allow further study of the substance 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil as a promising in the treatment of HIV-1.