盐酸表柔比星混合杂质对照品的研究与制备

Study and preparation of reference materials containing mixed impurities of epirubicin hydrochloride

目的研究盐酸表柔比星的杂质谱并制备混合杂质对照品。方法通过对盐酸表柔比星杂质谱的研究,选择合适的目标杂质;采用控速降解条件结合添加工艺杂质,优化制备工艺,研制了混合杂质对照品;以质谱法和单体对照品对照法,鉴定了混合杂质对照品中各主要杂质。结果制备了含有6种主要杂质的盐酸表柔比星混合杂质对照品,可用于有机杂质峰的确认。结论在杂质谱研究基础上,研制混合杂质对照品,不仅可有效评价色谱体系对各杂质的分离效能,还可快速准确归属多个杂质色谱峰,为分析杂质来源、评价样品质量提供依据。

Objective To investigate the impurity profile of epirubicin hydrochloride and to prepare reference materials containing mixed impurities. Methods Appropriate impurities were chosen as indicating impurities based on the impurity profile of epirubicin hydrochloride. Reference materials containing mixed impurities were prepared by the controlled degradation process and the addition of process impurity. The main impurities in reference materials were identified by mass spectrometry and single reference standard each. Results Reference materials containing six main impurities were successfully prepared to identify the organic impurity peaks by LC chromatograms. Conclusion The preparation of reference materials containing mixed impurities based on the impurity profile can be used for analyzing the source of impurities and evaluating the drug quality by evaluating the chromatographic performance of different separation systems and providing rapid identification of the impurity peaks.