UDK: 543.544.32:615.453.66

DEVELOPMENT AND VALIDATION OF ASSAY FOR KEMANTANE TABLETS BY GAS LIQUID CHROMATOGRAPHY

A. V. Tolkacheva, L. N. Grushevskaya, N. I. Avdyunina, B. M. Pyatin, L. M. Gaevaya, A. S. Miheeva, V. I. Prokofeva, E. V. Blinskaya

Научно-исследовательский институт фармакологии им. В. В. Закусова, Москва, Первый Московский государственный медицинский университет им. И. М. Сеченова

Abstract

The objective of this study was to develop and to validate a new assay of the active ingredient in Kemantane tablets by GC-FID. Chromatographic separation was performed on the fused silica capillary column - W COT Fused Silica CP-WAX 52 CB: 50 m, 0,32mm, 1,2 m. Parameters of the chromatographic system suitability and robustness of the technique were determined. The developed technique was validated; several serial samples of Kemantane tablets 100 mg were analyzed.

Keywords

kemantane, tablets, 5-hydroxyadamantan-2-one, assay, validation, gas liquid chromatography, GLC.

Contacts

Толкачева Анна Валентиновна — м. н. с. ОТО ФГБУ «НИИ фармакологии имени В. В. Закусова», аспирант кафедры фармацевтической и токсикологической химии ГБОУ ВПО Первый МГМУ им. И. М. Сеченова, e-mail: av-tolkacheva@rambler.ru