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气相色谱法同时测定卡莫司汀原料中3种有机溶剂残留量 预览

Simultaneous Determination of Three Residual Organic Solvents in Carmustine by Gas Chromatography
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摘要 目的建立同时测定卡莫司汀原料中3种残留溶剂[甲酸、乙醇和N,N-二甲基甲酰胺(DMF)]的气相色谱(GC)法。方法色谱柱采用HP-FFAP毛细管柱,载气为氮气,FID检测器,进样口温度为200℃,检测器温度为230℃,程序升温,以甲醇为溶剂,采用直接进样方式,测定3种残留溶剂的残留量。结果甲酸、乙醇和DMF在各自的质量浓度范围内均具有良好的线性关系(r均大于0.99),平均回收率均在98.0%以上(n=9)。结论该方法采用直接进样方式提高了甲酸和DMF的灵敏度,操作简便,成本低廉,结果准确,重复性好,可更好地控制药品质量。 Objective To establish a gas chromatography( GC) method for simultaneous determination of three residual solvents [ formic acid, ethanol and N, N-dimethylformamide( DMF) ] in carmustine raw materials. Methods HP-FFAP capillary column was used with nitrogen as the carrier gas and FID detector. The inlet temperature was 200 ℃,the detector temperature was 230 ℃,temperature programmed. The three residual solvents were determined by direct injection with methanol as solvent. Results The formic acid,ethanol and DMF had good linear relationships in their respective concentration ranges( r > 0. 99). The average recovery rates of formic acid,ethanol and DMF were more than 98. 0%( n = 9). Conclusion This method improves the sensitivity of formic acid and DMF by direct injection. It is easy to operate,and it has low cost,accurate results and good repeatability,which can better control the quality of carmustine.
作者 韩彬 高燕霞 庞文哲 张轶华 HAN Bin;GAO Yanxia;PANG Wenzhe;ZHANG Yihua(Hebei Institute for Drug Control, Shijiazh uang, Hebei, China 050011)
出处 《中国药业》 CAS 2019年第3期29-31,共3页 China Pharmaceuticals
关键词 气相色谱法 卡莫司汀 残留溶剂 质量控制 gas chromatography carmustine residual solvent quality control
作者简介 第一作者:韩彬,女,大学本科,研究方向为药品质量标准和药物分析,(电子信箱)13933853331@139.com;通信作者:张轶华,女,硕士研究生,研究方向为药品质量标准和药物分析,(电子信箱)zhangyihua0915@163com
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