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目的研究盐酸雷洛昔芬的杂质谱,为质量标准制定提供依据。方法采用高效液相色谱-离子阱-飞行时间质谱联用技术分析盐酸雷洛昔芬破坏后的样品及杂质对照品,研究各杂质的来源,并根据已知杂质的质谱裂解规律,对未知杂质的结构进行推定。结果盐酸雷洛昔芬经破坏后,共产生3个杂质,其中1个为未知杂质。雷洛昔芬及其杂质的质谱裂解呈现很强的规律性,据此推测未知杂质为雷洛昔芬进一步氧化生成的砜。结论本实验深入研究了盐酸雷洛昔芬的杂质谱,对盐酸雷洛生产过程中杂质的控制与体内药物分析具有指导意义。
Objective To study the impurity spectrum of raloxifene hydrochloride and provide the basis for the establishment of quality standards. Methods The samples were analyzed by high performance liquid chromatography-ion trap-coupled with time-of-flight mass spectrometry (RIA-LC-MS / MS). The source of each impurity was studied. According to the mass spectrometric cleavage of known impurities, The structure of the presumption. Results After raloxifene hydrochloride was destroyed, three impurities were produced, of which one was unknown. Mass spectrometry lysis of raloxifene and its impurities showed a strong regularity, suggesting that the unknown impurity is the sulfone which is further oxidized by raloxifene. Conclusion In this study, the impurity profile of raloxifene hydrochloride was studied in depth. It is instructive for the control of impurities in the process of Valeo Hydrochloride production and in vivo drug analysis.