Development of techniques to identify and determine the active ingredient in dental gel composition

• Main Authors: L. L. Davtyan, D. V. Reva, O. V. Chubenko, V. V. Trohumchuk
• Format: Article
• Language: Ukrainian
• Published: The State Expert Center of the Ministry of Health of Ukraine 2018-08-01
• Series: Фармацевтичний журнал
• Subjects: HPLC; decamethoxine; lidocaine hydrochloride; mobile phase; quantitative content; standard solution
• Online Access: https://pharmj.org.ua/index.php/journal/article/view/124/96
• ISSN: 0367-3057; 2617-9628

The technique of the qualitative and quantitative determination of active substances – decamethoxine and lidocaine hydrochloride in a new combination drug for preventing and treating inflammatory diseases of the oral cavity was developed.The aim of the work was to develop a methodology to identify and determine the active pharmaceutical ingredient in the composition of the dental gel.The objects were specimens of the developed dental gel containing lidocaine hydrochloride and decamethoxine. The study was conducted using high performance liquid chromatography (HPLC).The conditions for HPLC chromatographic investigations, providing sufficient selectivity and separation efficiency of the gel components were proposed.It was determined that the content of the dental gel component is within acceptable limits, and metrological characteristics of the method allow to recommend it to control the gel quality. 1 gram of the gel contains: decamethoxine – 0.591 mg/g (at a rate of 0.45–0.55 mg/g), lidocaine hydrochloride – 0.396 mg/g (at a rate of 0.36–0.44 mg/g).Approximate retention time of decamethoxine peak is 18.4 min, lidocaine hydrochloride – 13.5 min. Retention time of the peak of decamethoxine and lidocaine hydrochloride investigational solution and reference solution did not exceed 2%.