应用高分辨率HPLC-MS /MS方法对药物“洛莫司汀”物质中的杂质进行鉴定和定量测定

I.O. Reshetnikova, S. V. Metlitskikh, N. D. Stekleneva, A. Volov
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引用次数: 0

摘要

由于俄罗斯联邦“发展制药和医疗工业”国家计划(Pharma-2020)延长至2024年,因此对直接在俄罗斯联邦境内组织进口药物的生产和质量控制的可能性的兴趣大大增加。在这种情况下,列入“必需和基本药物”和“提供必要药物”清单[1]的药物尤为重要。恶性肿瘤化疗中常用的药物之一是“洛莫司汀”,其有效成分为1-(2-氯乙基)-3-环己基-1-亚硝基脲[1-3]。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of the high-resolution HPLC–MS/MS method for identification and quantitative determination of impurities in the substance of the drug «Lomustine»
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].
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