气相色谱法测定盐酸帕洛诺司琼中的有机残留溶剂

Determination of the Residual Organic Solvents in Palonosetron Hydrochloride by Gas Chromatography

目的:建立测定盐酸帕洛诺司琼中有机溶剂残留量的方法。方法:采用气相色谱法测定,FID检测器,以氮气为载气,色谱柱为AT.CE-30(60 m×0.53 mm,5.0μm);程序升温,起始温度为40℃,维持5 min,以15℃·min^(-1)的速率升温至140℃,维持10 min。结果:3批样品中有机溶剂残留量符合要求,建立的方法对各溶剂峰能很好分离,线性关系良好,各溶剂回收率均得到满意结果。结论:该方法简单、快速、灵敏度高,能有效的控制盐酸帕洛诺司琼中残留溶剂量。

Objective： To establish a capillary gas chromatography method for the determination of the residual organic solvents in palonosetron hydrocldoride. Method： A capillary gas chromatography method was established with FID detector and nitrogen as the carrier gas. A capillary column of AT. CE-30 （60 m ×0. 53 mm,5.0 μm） was used . The column temperature was increased by programming. The initial temperature was 40 ℃, maintained for 5 minutes, then raised to 140℃ with a rate of 15 ℃ ·min^ -1 maintained for 10 minutes. Result： The contents of residual solvents in three batches of samples were in accord with the specific requirements, and the linear ranges and the recoveries for residual solvents were satisfactory with good separation. Conclusion： The method is proved to be simple, rapid and sensitive. It is effective in analysis of the five solvents.