顶空毛细管气相色谱法测定帕瑞昔布钠中的残留溶剂含量

发布时间：2019-05-19 17:09

【摘要】：目的采用顶空气相色谱法,建立帕瑞昔布钠中甲醇、乙醇、二氯甲烷、正己烷和环己烷5种有机残留溶剂的测定方法。方法色谱柱为Agilent DB-624(30 m×0.32 mm,1.8μm)毛细管柱,采取程序升温,检测器为氢火焰离子化检测器,检测器温度为250℃,进样口温度为200℃,二甲基亚砜为溶剂,采用外标法计算残留溶剂的含量。结果在现定色谱条件下,甲醇、乙醇、二氯甲烷、正己烷和环己烷色谱峰均能达到有效分离,在考察的质量浓度内线性关系良好(r≥0.999 0),平均回收率为98.7%~100.8%(RSD5%,n=9),定量限分别为0.51、0.43、0.50、0.29和0.08 mg·L-1。结论该法适用于帕瑞昔布钠原料药中5种有机残留溶剂的含量测定。
[Abstract]:Objective to establish a headspace gas chromatography method for the determination of methanol, ethanol, dichloromethane, n-hexane and hexane in Paracyb sodium. Methods the chromatographic column was Agilent DB-624 (30 m 脳 0.32 mm, 1.8 渭 m) capillary column. The detector was hydrogen flame ionization detector, the detector temperature was 250 鈩，

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