Abstract

Pharmaceutical development is a mandatory component of the technological regu-lations and the registration dossier for a medicinal product. Establishing the methodological foundations for quality control and the physicochemical properties of medicines is a crucial task for the introduction and production of high-quality, effective, and safe pharmaceuticals. A reasoned choice of methods for the analysis of dosage forms allows for the optimization of the quality control system at a pharmaceutical enterprise and en-sures the economic efficiency of control and measuring equipment usage. The most important characteristic of a medicinal product is its quality. Quality control of medicinal substances and dosage forms is regulated by the relevant monographs of the State Pharmacopoeia of Ukraine or Europe. Therefore, the development and introduction into production of domestic drugs that meet the established quality requirements is a timely task for the fields of medicine and pharmacy. The spectrophotometric method for the test "Assay" of the drug Favipiravir, film-coated tablets, 200 mg, was validated. A systematic study of its chemical-analytical and metrological parameters was conducted. The method was validated according to the in-dicators of specificity, accuracy, precision, and linearity in the studied concentration range, in accordance with the requirements of the State Pharmacopoeia of Ukraine.

Keywords: favipiravir, tablets, spectrophotometry, validation

Article language: Ukr.