Abstract

The aim of the work was to estimate the quantitative content of 0.05 % chlorhexidine solution by capillary electrophoresis.Materials and methods. The object of the study was the drug 0.05 % solution of chlorhexidine for local and external use of pharmacopoeia quality. The study was carried out on a Kapel-104T device, equipped with an ultraviolet photometric detector and personal computer with the Multichrom software.Electrophoretic determination of the quantitative content of chlorhexidine was carried out in the UV region of the spectrum at a wavelength of 254 nm with a positive voltage on a capillary of 16 kV and a recommended capillary thermostating from 20 °C to 30 °C. The sample was introduced in pneumatical mode in the 30 mbar for 5 seconds. The analysis time was 5 minutes. As the leading electrolyte an aqueous solution consisting of 0.6 % solution of imidazole, 0.6 % solution of sodium tetraborate and 0.5 % solution of tartaric acid were used. The determination of chlorhexidine in the test solution was carried out in the UV spectral region at a wavelength of 254 nm, since at this wavelength one of the absorption maxima of the indicated drug was observed.Results. The validation analysis showed that the technique is characterized by specificity, linearity in the concentration range from 100 μg/ml to 700 μg/ml (y = 0.3438х - 12.4789; r = 0.9913), accuracy for chlorhexidine levels of 80–120 % (R = 98.82–100.44 %), precision (Sr = 0.44–0.61 %). The relative error of the result of separate determination of chlorhexidine in 0.05 % solution using capillary electrophoresis was 1.28 %.Conclusions. Quantitative determination of 0.05 % chlorhexidine solution by capillary electrophoresis was carried out and the parameters of the validation of the electrophoretic technique were established. The proposed electrophoretic conditions can serve as the basis for the development of methods for the quantitative determination of chlorhexidine bigluconate as part of this drug.

Highlights

  • Chlorhexidine is one of the leading antiseptics of a wide spectrum of action, represented on the Russian pharmaceutical market

  • The purpose of this work was to assess the quantitative content of 0.05 % chlorhexidine solution by capillary electrophoresis

  • Determination of the specificity of the electrophoretic technique was carried out by comparative analysis of electrophoregrams of standard sample (SS) chlorhexidine (Fig. 1) with 0.05 % solution of chlorhexidine for local and external application (Fig. 2), which revealed the coincidence of chlorhexidine peaks in the test and standard solutions by migration time

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Summary

Introduction

Chlorhexidine is one of the leading antiseptics of a wide spectrum of action, represented on the Russian pharmaceutical market. Chlorhexidine, which has been used for more than half a century as a curative and therapeutic-prophylactic antiseptic and disinfectant for various infections. It is widely used in disinfectological, surgical, obstetric-gynecological, dental, dermatologereal and urological practices [1,2,3]. It should be noted that the assortment list of drugs containing chlorhexidine as an active ingredient is quite diverse. This drug is presented in the form of liquid, solid and soft dosage forms. The latter is listed in the list of vital and essential medicines for medical use for 2018 and is characterized by fairly large share of the presence in the pharmacy nomenclature

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