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雌二醇中残留溶剂测定方法的建立

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建立顶空气相色谱法,同时测定雌二醇中的残留溶剂甲醇和乙醇。采用以6%氰丙基和94%二甲基聚硅氧烷为固定相的毛细管柱作为色谱柱,用氢火焰离子化检测器检测。方法学验证结果表明:甲醇质量浓度为2。01~20。1 μg/mL时残留溶剂线性关系良好(r=0。999 8),乙醇质量浓度为2。00~24。0 μg/mL时残留溶剂线性关系良好(r=0。999 8);甲醇回收率分别为106。9%、102。2%、100。8%,乙醇回收率为104。3%、103。8%、105。9%。该方法专属性强、灵敏度高、准确性好,可用于雌二醇中残留溶剂的测定。
Establishment of a Method for Determination of Residual Solvent in Estradiol
The paper established a headspace gas chromatography method and simultaneously determined the residual solvents methanol and ethanol in estradiol.The paper uses a capillary column with 6%cyanopropyl and 94%dimethylpolysiloxane as stationary phases as the chromatographic column,and is detected by a hydrogen flame ionization detector.The methodological validation results indicate that methanol ranges from 2.01 to 20.1 μ.The linear relationship is good within the range of g/mL(r=0.999 8),and ethanol ranges from 2.00 to 24.0 µ.The linear relationship is good within the range of g/mL(r=0.999 8);The recovery rates of methanol are 106.9%,102.2%,and 100.8%,respectively,while the recovery rates of ethanol are 104.3%,103.8%,and 105.9%.This method has strong specificity,high sensitivity,and good accuracy,and can be used for the determination of residual solvents in estradiol.

estradiolresidual solventgas chromatography

高慧如、彭飞城、谭英、李昭、盛忻、石笑弋

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湖南省药品检验检测研究院,湖南长沙 410001

国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙 410001

雌二醇 残留溶剂 气相色谱

2024

工业微生物
全国工业微生物信息中心 上海市工业微生物研究所

工业微生物

影响因子:0.293
ISSN:1001-6678
年,卷(期):2024.54(2)
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