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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 method for the determination of organic solvent residues in palonosetron hydrochloride. Methods: Gas chromatography was used to determine the FID detector with nitrogen as the carrier gas. The chromatographic column was AT-CE-30 (60 m × 0.53 mm, 5.0 μm). The temperature was programmed and the initial temperature was 40 ℃, The temperature was increased to 140 ° C at a rate of 15 ° C · min -1 for 10 min. Results: The residual amount of organic solvents in the three batches of samples met the requirements. The established method can separate the solvent peaks well and has a good linear relationship. The recovery of each solvent is satisfactory. Conclusion: The method is simple, rapid and sensitive. It can effectively control the amount of residual solvent in palonosetron hydrochloride.