Application of the high-resolution HPLC–MS/MS method for identification and quantitative determination of impurities in the substance of the drug «Lomustine»

Abstract

Due to the state program of the Russian Federation "Development of the pharmaceutical and medical industry" (Pharma-2020), extended until 2024, the interest in the possibility of organizing the production and quality control of imported medicinal substances directly on the territory of the Russian Federation has significantly increased. In this case, the drugs included in the lists of "Indispensible and essential drugs" and "Provision of necessary drugs" [1] are of particular importance. One of the drugs often used in the chemotherapy of malignant tumors is the drug "Lomustine", which includes 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea as an active ingredient [1-3].