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为了研究尼麦角林及其制剂中的有关物质,采用电喷雾正离子化-飞行时间质谱法(ESI-TOF/MS)测定各有关物质的准确质量,三重四极质谱(ESI-MS/MS)测定子离子特征。根据对照品比对、质谱裂解分析,结合合成工艺与强制降解实验,检测并鉴定了尼麦角林及其制剂中的16个主要有关物质(8个合成副产物、8个降解产物),为尼麦角林生产工艺控制和质量保障提供参考依据。
In order to study the related substances in nicergoline and its preparation, the accurate mass of each substance was determined by electrospray ionization-time of flight mass spectrometry (ESI-TOF / MS). The triple quadrupole mass spectrometry (ESI-MS / MS) Determination of ion characteristics. According to the comparison of reference materials, mass spectrometric lysis analysis, combined with synthetic technology and forced degradation experiments, 16 major related substances (8 synthetic by-products and 8 degradation products) in nicergoline and its preparation were detected and identified. Ergoline production process control and quality assurance provide a reference.