| 顶空毛细管气相色谱法测定美司钠原料和注射液的残留溶剂 |
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| 引用本文： | 张秉华,王小亮,郭欢迎,马丽. 顶空毛细管气相色谱法测定美司钠原料和注射液的残留溶剂[J]. 西北药学杂志, 2019, 0(1): 39-43 |
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| 作者姓名： | 张秉华 王小亮 郭欢迎 马丽 |
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| 作者单位： | 1.陕西省食品药品监督检验研究院;2.咸阳市中心医院药学部 |
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| 摘 要： | 目的建立美司钠原料及其注射剂中4种残留溶剂的顶空毛细管气相色谱测定方法。方法使用HP-1毛细管气相色谱柱(30m×0.25mm,0.25μm),采用程序升温。初始温度为40℃,保持5min,再以20℃·min-1升温至150℃;进样口温度为200℃;检测器为FID;检测器温度为250℃。顶空进样,平衡温度为75℃,平衡时间为30min。结果同时测定了美司钠原料和注射液中4种残留有机溶剂,甲醇、乙醇、异丙醇和丙酮分离度均在2.0以上,线性范围分别为6.6～66.0(r1=0.999 4),4.9～49.1(r2=0.999 9),5.8～58.0(r3=0.999 5)和8.0～80.0μg·mL-1(r4=0.999 6),平均加样回收率分别为97.3%,98.2%,99.5%和99.1%,RSD值分别为1.9%,2.1%,1.5%和1.7%。结论该方法灵敏、准确,可用于美司钠原料及其注射液中残留溶剂的检测。
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| 关 键 词： | 美司钠 顶空气相色谱法 残留溶剂 |
Determination of residual solvents in mesna crude material and injection by headspace capillary gas chromatography |
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| ZHANG Binghua,WANG Xiaoliang,GUO Huanying,MA Li. Determination of residual solvents in mesna crude material and injection by headspace capillary gas chromatography[J]. Northwest Pharmaceutical Journal, 2019, 0(1): 39-43 |
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| Authors: | ZHANG Binghua WANG Xiaoliang GUO Huanying MA Li |
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| Affiliation: | (Shaanxi Institute for Food and Drug Control,Xi′an 710065,China;Department of Pharmacy,the Central Hospital of Xianyang,Xianyang 712000,China) |
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| Abstract: | ZHANG Binghua;WANG Xiaoliang;GUO Huanying;MA Li(Shaanxi Institute for Food and Drug Control,Xi′an 710065,China;Department of Pharmacy,the Central Hospital of Xianyang,Xianyang 712000,China) |
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| Keywords: | mesna headspace capillary gas chromatography residual solvents |
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