UDK: 615.453.6:615.012.8

DEVELOPMENT AND VALIDATION OF IMPURITY DETERMINATION TECHNIQUE IN TABLETS OF RU 1205, A NOVEL KAPPA OPIOID AGONIST

A. A. Illarionov, L. N. Grushevskaya, L. M. Gaevaya, N. I. Avdyunina, B. M. Pyatin, K. V. Alekseev, I. V. Bogunova

НИИ фармакологии имени В. В. Закусова, Москва

Abstract

We developed a new technique for impurity determination in RU 1205 tablets using HPLC. We identified such validation characteristics as linearity, range of application, limits of detection and quantitative determination of impurities, convergence and correctness. We established suitability criteria for chromatography methods. We measured impurities in RU 1205 serial tablet samples.

Keywords

RU 1205, tablets, pharmaceutical analysis, validation, analysis technique, high-performance liquid chromatography, HPLC, impurities.

Contacts

Илларионов Александр Анатольевич — аспирант опытно-технологического отдела ФГБУ «НИИ фармакологии имени В. В. Закусова» РАМН, e-mail: otopharm@mail.ru