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,1.8μm)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1μL。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。
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.
出处
《中国现代应用药学》
CAS
CSCD
2014年第11期1377-1379,共3页
Chinese Journal of Modern Applied Pharmacy
基金
"重大新药创制"科技重大专项(2009ZX09301-012)