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气相色谱-质谱联用仪测定索磷布韦原料中苯残留方法

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文章采用交联聚乙二醇毛细管色谱柱,程序升温,进样口温度200 ℃,炉温85 ℃,平衡30 min,载气为氦气,流速1.0 mL/min,分流比为25︰1,进样量为1 mL,建立了气相色谱-质谱联用法测定索磷布韦原料药中苯残留的测定方法.结果显示:苯在质量浓度范围内与色谱峰面积线性关系良好,相关系数不小于0.999,方法检出限不大于2 μg/mL,样品加标回收率为90.0%~108.0%.该方法灵敏度高,结果准确,可用于索磷布韦原料中苯残留的测定.
Method for Determination of Benzene Residues in Sofosbuvir Raw Materials by Gas Chromatography-mass Spectrometry
A method for the determination of benzene residues in sofobuvir was established by gas chromatogen-mass spectrometry using a cross-linked polyethylene glycol capillary column with temperature program,inlet temperature 200 ℃,furnace temperature 85 ℃,balance for 30 min,helium carrier gas,flow rate 1.0 mL/min,shitter ratio 25︰1,and sample size 1 mL.The results showed that benzene had a good linear relationship with chromatographic peak area in the range of mass concentration,the correlation coefficient was no less than 0.999,the detection limit was no more than 2 μg/mL,and the recovery rate was 90.0%~108.0%.The method has high sensitivity and accurate results,and can be used for the determination of benzene residues in sofosbuvir raw materials.

sofosbuvirbenzene residuemass spectrumgas chromatographychemical analysis

柴倩雯、敦康、郭永辉

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河北省药品职业化检查员总队(南片区),河北石家庄 050091

河北省药品审评中心,河北石家庄 050091

河北省药品医疗器械检验研究院,河北石家庄 050071

索磷布韦 苯残留 质谱 气相色谱 化学分析

2024

化工管理
中国化工企业管理协会

化工管理

影响因子:0.336
ISSN:1008-4800
年,卷(期):2024.(26)