Abstract

The problem of quality control is always relevant for medicines. In the treatment of tuberculosis this is especially important since violations of the dosage regimen as a result of an underestimated or overestimated content of the active substance in combination with many other factors can cause the development of drug-resistant forms of the disease that are extremely difficult to treat. The object of this study is terizidone – a reserve drug used in cases of tuberculosis with broad and multiple resistance. Currently, the search for methods with not only high selectivity and sensitivity, but also more affordable, not requiring expensive devices, consumables and toxic reagents continues. Modern methods proposed by regulatory documentation, involve the use of standard samples. They are one of the main factors leading to the rise in the cost of the method due to their foreign production. One of the ways to carry out quantitative determination in the absence of standard samples is the spectrophotometric method using external optical comparison samples. As such inorganic salts are proposed: potassium hexacyanoferrate (III) and potassium dichromate. Based on the data of the study of the optical properties of the drug, optimal conditions for spectrophotometric determination were selected, conversion coefficients were calculated. Thus methods have been developed for the quantitative evaluation of terizidone in substance and dosage form capsules of 0.3 g. The developed methods are subjected to validation evaluation according to such indicators as specificity, convergence, reproducibility, linearity, analytical area of the methodology. The results obtained confirm the suitability of the methodology for the purpose for which it was developed.

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