Developing a quantification procedure for ethylmethylhydroxypyridine succinate in an injection solution

Introduction. Ethylmethylhydroxypyridine succinate is a unique medicinal product developed by Russian

scientists. It is widely used in clinical practice as a drug with antioxidant and membrane-stabilizing properties. Manufacturing the ethylmethylhydroxypyridine succinate-based drugs is classified as a full-cycle process encompassing

the entire pharmaceutical substance synthesis through to the final dosage form. Ethylmethylhydroxypyridine succinate-

based drugs are available on the pharmaceutical market in solid and liquid dosage forms as mono- and combined

medications. The most clinically popular dosage form is ethylmethylhydroxypyridine succinate solution for intravenous

and intramuscular injections (50 mg/ml), which has the best pharmacokinetic properties. In this regard, the therapeutic

significance of ethylmethylhydroxypyridine succinate injection solution and the widespread use of this drug on the

pharmaceutical market necessitate a thorough assessment of its quality, primarily regarding the quantitative content of the

active ingredient. Currently, the State Pharmacopoeia of the Russian Federation regulates the quantitative determination

of ethylmethylhydroxypyridine succinate in injection solution by ultraviolet spectrophotometry. Furthermore, the results of

studies have been published regarding the development of a quality control procedure for the ethylmethylhydroxypyridine

succinate injection solution using high-performance liquid chromatography. Capillary electrophoresis may serve as an

alternative quantitative procedure for detecting the ethylmethylhydroxypyridine succinate in an injection solution. Aim.

To develop an electrophoretic quantitative procedure for ethylmethylhydroxypyridine succinate in an injection solution.

Materials and Methods. The object of the study was a medicinal product, i. e., an intravenous and intramuscular injection

solution of ethylmethylhydroxypyridine succinate, registered in the Russian Federation under the trade name “Mexidol,

solution for intravenous and intramuscular administration, 50 mg/ml” (Armavir Biofactory FKP, Russia). Electrophoretic

determination and detection were carried out using the Kapel-105M capillary electrophoresis system (OAO NPF Lumex,

Russia) equipped with a spectrophotometric detector, at a wavelength of 297 nm. An aqueous solution containing a

0.48% solution of boric acid, 0.1 M of sodium hydroxide solution, and a 1.0% solution of ethylmethylhydroxypyridine

succinate, acted as the leading electrolyte. Results and Discussion. In determining the validation parameters, it

was found that the proposed method is characterized by specificity, linearity in the concentration range from 0.4% to

1.0% (y = 955.07x-16.132; r = 0.996), correctness for ethylmethylhydroxypyridine succinate content levels of 80-120%

(R = 98.71%-101.09%), and precision (RSD = 0.372-0.815%). Conclusions. A procedure has been developed and

validated for determining the quantitative content of ethylmethylhydroxypyridine succinate in an injection solution by

capillary electrophoresis.