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

V. Yu. Anisimov, V. O. Gelmboldt, S. M. Gubar, A. V. Myhal, N. Yu. Bevz, V. A. Georgiyants

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.


Keywords


cetylpyridinium hexafluorosilicate; gel; assay; HPLC method; validation

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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.

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GOST Style Citations


1.        Lepsky, V. V. Biochemical mechanisms of the caries prophylaxis action of hexafluorosilicates / V. V. Lepsky, V. Yu. Anisimov, V. V. Lepsky // J. of Education, Health and Sport. – 2015. – Vol. 5, Issue 11. – Р. 289–299.

2.         Анісімов, В. Ю. Розробка складу та технології карієспрофілактичного гелю / В. Ю. Анісімов, В. О. Гельмбольдт, Н. П. Половко // Вісник фармації. – 2015. – № 4 (84). – С. 58–61.

3.         Development of methods for identification of cetylpyridinium hexafluorosilicate / V. O.Gelmboldt, V. Yu. Anisimov, N. Yu. Bevz, V. A. Georgiyants // Der Pharma Chemica. – 2016. – Vol. 8, Issue 1. – P. 169–173.

4.         Development of the quantitative determination method for a new caries–preventive compound / V. Yu. Anisimov, V. O. Gelmboldt, N. Yu. Bevz, V. A. Georgiyants // Вісник фармації. – 2016. – № 1 (85). – С. 15–18.

5.         Державна фармакопея України : в 3-х т. / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2–е вид. – Х. : Український науковий фармакопейний центр якості лікарських засобів, 2015. – Т. 1. – 1128 с.





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

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