The use of the HPLC method for the quantitative determination of cetylpyridinium hexafluorosilicate in a dental gel

Authors

  • V. Yu. Anisimov Odessa National Medical University, Ukraine
  • V. O. Gelmboldt Odessa National Medical University, Ukraine
  • S. M. Gubar National University of Pharmacy, Ukraine
  • A. V. Myhal National University of Pharmacy, Ukraine
  • N. Yu. Bevz National University of Pharmacy, Ukraine
  • V. A. Georgiyants National University of Pharmacy, Ukraine

DOI:

https://doi.org/10.24959/nphj.17.2180

Keywords:

cetylpyridinium hexafluorosilicate, gel, assay, HPLC method, validation

Abstract

Cetylpyridinium hexafluorosilicate has been proposed as a caries preventive and antibacterial agent for use as a gel for oral application, which requires development of quality control methods.

Aim. To develop the method for the quantitative determination of cetylpyridinium hexafluorosilicate in a dosage form using HPLC.

Materials and methods. The object of the study is the experimental dosage form – a gel proposed for use in dental practice. The research method is HPLC.

Results and discussion. The method for the quantitative determination of the active component, which allows determining cetylpyridinium hexafluorosilicate in the gel in the presence of excipients of the dosage form, has been developed. It is recommended to carry out this determination by the HPLC method using the column of 150 × 4.6 mm in size filled with octadecyl silica gel for chromatography, the sorbent particle size of 3.5 μm, a mixture of perchlorate buffer solution (pH 3.0) and acetonitrile (30 : 70) as a mobile phase and UV detection at the wavelength of 254 nm.

Conclusions. The conditions of the chromatographic study by the HPLC method proposed provide sufficient selectivity for the quantitative determination of cetylpyridinium hexafluorosilicate in the dosage form, and it has been confirmed by studying the validation characteristics of the method.

Author Biographies

V. Yu. Anisimov, Odessa National Medical University

associate professor of the Pharmaceutical Chemistry Department, dean of the Pharmaceutical Faculty

V. O. Gelmboldt, Odessa National Medical University

professor, the head of the Pharmaceutical Chemistry Department

S. M. Gubar, National University of Pharmacy

head of the State Research Laboratory on Drug Quality Control

A. V. Myhal, National University of Pharmacy

postgraduate student of the Pharmaceutical Chemistry Department

N. Yu. Bevz, National University of Pharmacy

associate professor of the Pharmaceutical Chemistry Department

V. A. Georgiyants, National University of Pharmacy

Doctor of Pharmacy (Dr. habil.), professor, head of the Pharmaceutical Chemistry Department

References

Lepsky, V. V., Anisimov, V. Yu., Lepsky, V. V. (2015). Biochemical mechanisms of the caries prophylaxis action of hexafluorosilicates. Journal of Education, Health and Sport, 5 (11), 289–299.

Anisimov, V. Yu., Helmboldt, V. O., Polovko, N. P. (2015). Vìsnik farmacìï, 4 (84), 58–61.

Gelmboldt, V. O., Anisimov, V. Yu., Bevz, N. Yu., Georgiyants, V. A. (2016). Development of methods for identification of cetylpyridinium hexafluorosilicate. Der Pharma Chemica, 8 (1), 169–173.

Anisimov, V. Yu., Gelmboldt, V. O., Bevz, N. Yu., Georgiyants, V. A. (2016). Development of the quantitative determination method for a new caries–preventive compound. Vìsnik farmacìï, 1 (85), 15–18.

5. Derzhavna Farmakopeia Ukrainy, v 3 tomakh, 2–e vyd. (2015). Kharkiv: Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv, 1128.

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Published

2017-12-04

Issue

Section

Synthesis and Analysis of Biologically Active Substances