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Method for detecting dimethyl sulfate and diethyl sulfate in brivaracetam and application thereof
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CN122409914A
Pharmacy medicine
Pharmaceutical drug
本发明提供了一种布立西坦中硫酸二甲酯和硫酸二乙酯的检测方法及其应用,涉及药物分析化学技术领域,包括以下步骤:采用气相色谱‑串联质谱联用法检测布立西坦中硫酸二甲酯和硫酸二乙酯的含量;气相色谱的色谱柱为固定相6%氰丙基苯基‑94%二甲基聚硅氧烷的毛细管柱;质谱通过多反应监测模式监测离子对;离子对为硫酸二甲酯m / z 94.9→43.1和94.9→31.1,硫酸二乙酯m / z 65.9→48.0和139.0→31.1。本发明能够有效分离并高灵敏度、高专属性地测定布立西坦中痕量基因毒性杂质硫酸二甲酯和硫酸二乙酯的含量,准确性好,重复性好,对于保障布立西坦的用药安全与质量控制具有极其重要的意义。
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Owner:
HENAN NEWLAND PHARMACEUTICAL CO LTD
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