Abstract
Introduction. Quantitative assessment of the active substance is necessary and perhaps the most significant part of the drug quality control. Validation of the analytical methods of quantitative assessment ensures their compliance with high requirements. The present study describes the development and validation of a spectrophotometry method for the quantitative evaluation of the active substance in the drug form of the national antitumor and antiangiogenic drug «Dimeric macrocyclic tannin (DMT) lyophilizate for solution for injection, 100 mg».Aim. The development and validation of the assay method for the standardization of «DMT lyophilizate for solution for injection, 100 mg».Materials and metods. The study used «DMT lyophilizate for solution for injection, 100 mg» and the active substance DMT. Method – spectrophotometry.Results and discussion. The methodof the quantitative assessment of the active substance in the DMT lyophilized drug by direct UV spectrophotometry was developed and the validation characteristics of the method were defined as a result of the study.Conclusion. The validation results showed that the assay method of DMT in the drug form has the appropriate accuracy, precision and linearity. The obtained results correspond to the approved criteria that allow the use of the developed methodology for evaluating the quality of the drug.
Highlights
Quantitative assessment of the active substance is necessary and perhaps the most significant part of the drug quality control
The present study describes the development and validation of a spectrophotometry method for the quantitative evaluation of the active substance in the drug form of the national antitumor and antiangiogenic drug «Dimeric macrocyclic tannin (DMT) lyophilizate for solution for injection, 100 mg»
И. Разработка и валидация методики количественного определения цифетрилина в таблетках
Summary
Блохина» Минздрава России); ДМТ лиофилизат для приготовления раствора для инъекций 100 мг Для приготовления испытуемого раствора содержимое флакона растворяли в воде очищенной, количественно переносили в мерную колбу вместимостью 100 мл и доводили объём раствора до метки водой очищенной, перемешивали; 1 мл полученного раствора переносили в мерную колбу вместимостью 50 мл и доводили объём раствора до метки водой очищенной, перемешивали. Для приготовления раствора стандартного образца (СО) около 100 мг (точная навеска) субстанции ДМТ растворяли в воде очищенной, переносили в мерную колбу вместимостью 100 мл и готовили раствор в том же разведении, что и испытуемый раствор. X = A1 ⋅ a0 ⋅ C , A0 ⋅100 где A1 и A0 – оптическая плотность испытуемого раствора и раствора СО соответственно; а0 – навеска СО ДМТ, мг; Р – содержание ДМТ в СО, %
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