| 引用本文: | 胡莉华,李清,毕开顺,戴雯静,姬莉芳,郑晓娇.GC测定盐酸司维拉姆原料药中有机溶剂残留[J].中国现代应用药学,2014,31(11):1377-1379. |
| HU Lihua,LI Qing,BI Kaishun,DAI Wenjing,JI Lifang,ZHENG Xiaojiao.Determination of Residual Organic Solvents in Sevelamer Hydrochloride Drug Substance by GC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(11):1377-1379. |
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| 摘要: |
| 目的 建立以毛细管气相色谱法测定盐酸司维拉姆原料药中乙醇、异丙醇和环氧氯丙烷(ECH)3种有机溶剂残留量的方法。方法 采用DB-624(30.0 m×0.32 mm，1.8 μm)毛细管柱，载气为氮气，采用氢火焰离子化检测器(FID)，进样口温度为180 ℃，检测器温度为220 ℃，柱温采用程序升温，进样量1 μL。结果 乙醇、异丙醇和ECH均能得到较好的分离，呈现良好的线性关系，平均回收率分别为101.8%，101.3%，103.9%。结论 本方法简便快速，准确性好，灵敏度高，可用于盐酸司维拉姆原料药中残留溶剂的测定。 |
| 关键词: 毛细管气相色谱法 盐酸司维拉姆 环氧氯丙烷 有机溶剂残留量 |
| DOI： |
| 分类号: |
| 基金项目:“重大新药创制”科技重大专项(2009ZX09301-012) |
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| Determination of Residual Organic Solvents in Sevelamer Hydrochloride Drug Substance by GC |
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HU Lihua, LI Qing, BI Kaishun, DAI Wenjing, JI Lifang, ZHENG Xiaojiao
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School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
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| Abstract: |
| OBJECTIVE To establish a capillary GC method for the determination of residual organic solvents including alcohol, isopropanol, epichlorohydrin (ECH) in sevelamer hydrochloride drug substance. METHODS This method utilized an Agilent DB-624 GC column, helium as carrier gas. FID was used as detector with the temperature of 220 ℃, and the inlet temperature was 180 ℃. This method used temperature program. The injection volume was 1 μL. RESULTS The three residual organic solvents alcohol, isopropanol, ECH were completely separated, the linear relationship was good, and the average recoveries were 101.8%, 101.3%, 103.9%, respectively. CONCLUSION This method is simple, rapid, accurate and highly sensitive, which can be used for the determination of the residual organic solvents in sevelamer hydrochloride drug substance. |
| Key words: GC sevelamer hydrochloride epichlorohydrin residual organic solvents |
