Валидация методики количественного определения фенобарбитала при проведении теста «растворение» в таблетке сублингвальной «Корвалол»

Abstract

Проведена валидация методики количественного определения фенобарбитала при проведении теста «Растворение» методом высокоэффективной жидкостной хроматографии в таблетках сублингвальных «Корвалол».

Aim. To validate the method for quantitative determination of Phenobarbital at "Dissolution" test in accordance with the State Pharmacopoeia of Ukraine (SPhU) requirements; to prove by experimental research that the method allows reliably monitoring Phenobarbital content in the sublingual tablet “Corvalol”. Methods. HPLC method was used for research in accordance with the SPhU requirements. Results. The study of specificity criteria of method for Phenobarbital quantitative determination, its correctness, precision, linearity and robustness was carried out. It was determined, that the method meets the SPhU require-ments on the main validation parameters. Results of research were used for development of methods for quality control of sublingual tablets “Corvalol”. Conclusion. Validation of the method for quantitative determination of Phenobarbital in the remedy “Corvalol” sublingual tablets at "Dissolution" test in accordance with the State Pharmacopoeia of Ukraine (SPhU) re-quirements was carried out. It has been proven that the method meets the SPhU requirements on the specificity, correctness, precision, and robustness in the range of 60–120 % of the nominal content. The obtained data were used for development of methods for quality control of the remedy “Corvalol” sublingual tablets.