Studying the Validation Characteristics of Testing Methods for Authenticity and Quantitating Determination of Acysole in Dental Gel

Abstract

In the quality assurance system for medicinal products, an important role is played by the procedure for validation of analytical methods at the stages of development, testing, technology and serial production. The need for validation at the stage of drug development is due to the fact that it is possible to promptly identify the shortcomings of the method and significantly improve it. The purpose of this study is to validate methods for testing «The authenticity» and «Quantitative determination» of acyzole in dental gel. Materials and methods. To achieve this goal, an active pharmaceutical substance of pharmacopoeial quality was used. When developing methods for testing for “Authenticity,” a reaction with oxalic acid to the zinc cation determined in the composition of acyzole was used. For the quantitative determination of acyzole, the complexometric method was used. The objects of the study were three series of gel samples. Results and discussion. As a result of the research, a method for testing «Authenticity» was developed; it was found that the proposed method is characterized by a negative analytical signal on model mixtures free of the analyte component and placebo, and a positive analytical signal on model mixtures of various compositions containing the analyte component. The validation characteristics of methods for the quantitative determination of acyzole 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 assessing the validation characteristics of the proposed methods, it was established that the methods for testing the «Authenticity» and «Quantitative determination» of acyzole in the gel are specific, the methods of quantitative determination are characterized by accuracy and repeatability, a linear dependence in the analytical range of ±20% of the declared amount of acyzole, which allows them to be used for a reliable assessment quality of the developed dental gel.