Validation of quantitative determination methods of active substances in Carbatryl tablets

Abstract

Today, one of the promising areas of medicine and pharmacy, which reduces the side effects of drugs, is the creation of combined drugs which include antioxidant in addition to the main active ingredient, which reduces side effects and in some cases leads to their leveling. One such drug is thiotriazoline - a broad-spectrum antioxidant. Most antiepileptic drugs are available in tablet form, so this dosage form was proposed to create a new fixed, combined drug whose active ingredients are carbamazepine and thiotriazoline. We have previously developed a method for standardizing the active substances of carbamazepine with thiotriazoline (1.5: 1) in the model mixture, tablet mass and tablets. According to the requirements of the SPU, the next step was to validate the developed methods. That was the purpose of our work. Validation of the quantitative determination (quantification) method of active substances was carried out on the following indicators: specificity, linearity, range of application, correctness, accuracy and robustness. Studies have shown that the method is characterized by sufficient convergence, as the found value of the relative confidence interval of ΔΖ for thiotriazoline and carbamazepine does not exceed the critical value for the convergence of results (1.6%); sufficient correctness, as the criterion of insignificance of systematic error of the method is met. Systematic error of the method satisfies the requirements of statistical and practical insignificance. The high value of the correlation coefficient r = 0.99994 and 0.99991 satisfies the requirements of the acceptance criterion (r = 0.9998) and confirms the linearity of the relationship between taken and detected amount of thiotriazoline and carbamazepine in the range from 80% to 120% according to its nominal content in drugs. The requirements to the parameters of linear dependence (а, SD0/b, r) of the determination method of thiotriazoline and carbamazepine in the whole concentration range from 80% to 120% of the nominal value are met. Thus, the developed method of standardization of active substances in Carbatryl tablets is valid for the following indicators: specificity, linearity, convergence, correctness and can be included in the project of Quality Control Methods.