Validation of Analytical Methods for Quality Control of Gel for Dentin Remineralization

Abstract

Introduction. As a result of a complex of scientific and experimental studies carried out at the Department of Pharmaceutical Technology of the State Pharmacy of Pharmaceuticals, a gel was developed for remineralization of dentin in order to carry out drug treatment of medium and deep caries. In the developed gel, along with the remineralizing effect, an antibacterial effect was achieved, which is necessary in the treatment of dentin caries due to the introduction of chlorhexidine bigluconate (CHB). The proposed composition simultaneously contains the main remineralizing ions – calcium, phosphate and fluoride in a free active state. Due to this, a significant increase in their penetration into the dentin is ensured. During the preparation of regulatory documentation for the gel for the treatment of dentine caries, validation of methods designed to control the quality of active substances was carried out.Aim. Validation of methods for testing the authenticity and quantification of active substances in the gel for dentine remineralization.Materials and methods. To achieve this goal, active pharmaceutical substances of pharmacopoeial quality are used. When developing test methods, pharmacopoeial and non-pharmacopoeial reactions to reacting cations and anions were used. For the quantitative determination of the chloride compound, the complexometric method, the back titration method is used, for potassium phosphate, the disubstituted acidimetric method, for sodium fluoride, the photoelectrocolorimetric method, for chlorhexidine bigluconate, the lauryl sulfate method. The objects of study were five serial samples of gels.Results and discussion. As a result of the studies, methods of testing for authenticity were developed, it was found that the proposed methods are characterized by a negative analytical signal on model mixtures free of the analyte and placebo, and a positive analytical signal on model mixtures of various compositions containing the analyte. The validation characteristics of methods for the quantitative determination of active substances in the gel were studied, positive results were obtained, the proposed methods can be used for inclusion in the regulatory documentation for the developed gel.Conclusion. When evaluating the validation characteristics of the proposed methods, it was found that the methods of testing for authenticity and quantitative determination of active substances in the gel are specific, the methods of quantitative determination are characterized by accuracy and repeatability, a linear dependence in the analytical region of ±20 % of the declared amount of active substances, which allows them to be used for reliable assessment of the quality of the developed gel.