UDK: 615.012

ASSAY TECHNIQUE VALIDATION OF THE ADAMANTANE DERIVATIVE DRUG IN INJECTION DOSAGE FORM BY GLC

M.S. Sergeeva, L.N. Grushevskaya, L.M. Gaevaya, N.I. Avdyunina, M.E. Dudenkova, E.D. Denisenko, S.V. Minaev

ФГБНУ «НИИ фармакологии имени В.В. Закусова» РАМН

Abstract

Gas-liquid chromatography (GLC) is one of the most promising methods of adamantane derivatives analysis due to their sufficiently high volatility and resistance to high temperatures. The purpose of this study was validation of a previously developed technique for assay of gimantan injection by gas-liquid chromatography. Defined validation characteristics were specificity, linearity, limit of detection, limit of quantification, accuracy and precision, also the calculation of technique uncertainty was performed.

Keywords

gimantan, validation, assay, gas-liquid chromatography.

Contacts

Сергеева Мария Сергеевна – к. ф. н., старший научный сотрудник опытно-технологического отдела ФГБНУ НИИ фармакологии имени В.В. Закусова, e-mail: otopharm@mail.ru