离子色谱法检测富马酸伏诺拉生原料药中甲胺残留  

Determination of Methylamine Residue in Vonoprazan Fumarate Raw Material by Ion Chromatography

作　　者：冯文 周锐 刘峰 FENG Wen;ZHOU Rui;LIU Feng(Institute for Drug Control of Sichuan Province,Key Laboratory of In Vitro and In Vivo Correlation Technology for Pharmaceutical Preparations,National Medical Products Administration,Chengdu,Sichuan,China 611731)

机构地区：[1]四川省药品检验研究院·国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,四川成都611731

出　　处：《中国药业》2025年第6期78-81,共4页China Pharmaceuticals

基　　金：四川省药品监督管理局药品科技计划项目[2024013]。

摘　　要：目的建立检测富马酸伏诺拉生原料药中甲胺的离子色谱法。方法色谱柱为Dionex IonPac^(TM)CS-12A柱(250 mm×4 mm),流动相为4 mmol/L甲基磺酸溶液-60 mmol/L甲基磺酸溶液(梯度洗脱),流速为1.2 mL/min,进样量为25μL,柱温为35℃,检测方式为抑制电导检测。结果甲胺质量浓度在0.012~6.0μg/mL范围内与峰面积线性关系良好(r=1.0000);仪器的检测限和定量限分别为0.0036μg/mL和0.012μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为99.70%,RSD为1.05%(n=9)。结论该方法操作简便、快速,灵敏度高、专属性好,可准确测定富马酸伏诺拉生原料药中甲胺的残留量。Objective To establish an ion chromatography method for the determination of methylamine residue in vonoprazan fumarate raw material.Methods The chromatographic column was the Dionex IonPac^(TM)CS-12A column(250 mm×4 mm),the mobile phase was 4 mmol/L methanesulfonic acid solution–60 mmol/L methanesulfonic acid solution(gradient elution),the flow rate was 1.2 mL/min,the injection volume was 25μL,the column temperature was 35℃,and the detection method was suppressed conductivity detection.Results The mass concentration of methylamine showed a good linear relationship with peak area in the range of 0.012–6.0μg/mL(r=1.0000).The limits of detection and quantification were 0.0036μg/mL and 0.0120μg/mL,respectively.The RSDs of precision,stability,and repeatability tests were all lower than 2.0%.The average recovery rate was 99.70%with the RSD of 1.05%(n=9).Conclusion This method is simple,rapid,highly sensitive,and highly specific,and it can accurately determine the methylamine residue in vonoprazan fumarate raw material.

关 键 词：富马酸伏诺拉生 甲胺 离子色谱法 残留控制 

分 类 号：R917[医药卫生—药物分析学]