GC测定盐酸司维拉姆原料药中有机溶剂残留

Determination of Residual Organic Solvents in Sevelamer Hydrochloride Drug Substance by GC

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。

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.