Calcium folinate is a formylated derivative of tetrahydrofolate,used as a folate antagonist in the clinical treatment for anemia and tumors.In this paper,the chemical composition of calcium folinate-related impurities was analyzed by nuclear magnetic resonance technology,and an HPLC analysis method was established to investigate the effects of oxidation,acid,base,high temperature,and light irradiation on the degradation of calcium folinate.The main degradation pathways of calcium folinate were determined to be base destruction,acid destruction and oxidative destruction.This experiment was conducted to simulate the degradation process of calcium folinate with a variety of environments involved in forced degradation.The study helps to explore the related substances for quality control of calcium folinate API and its formulations.
关键词
亚叶酸钙/降解杂质/结构解析/核磁/质谱/高效液相色谱仪
Key words
calcium folinate/degradation impurities/structural analysis/nuclear magnetic resonance/mass spectrometry/high performance liquid chromatograph
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