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目的建立气相色谱法测定候选新药SM934中6种残留有机溶剂的含量。方法采用毛细管气相色谱法,使用DM-5石英毛细管柱(30 m×0.25 mm,0.25μm),采取程序升温,分离测定甲醇、乙醇、二氯甲烷、乙酸乙酯、石油醚和N,N-二甲基甲酰胺的残留量。结果 6种有机溶剂完全分离,线性范围为13.0～250.0 mg.L-1,精密度良好,加样回收率在97%～105%之间(RSD<4%)。结论本法灵敏、准确、可靠,适用于候选新药SM934质量控制中有机溶剂残留量的检测。
Objective To establish a gas chromatographic method for the determination of six residual organic solvents in candidate new drug SM934. Methods The sample was separated on a DM-5 quartz capillary column (30 m × 0.25 mm, 0.25 μm) by capillary gas chromatography. The contents of methanol, ethanol, methylene chloride, ethyl acetate, petroleum ether and N, N- Dimethylformamide residues. Results The six organic solvents were completely separated. The linear range was 13.0 ~ 250.0 mg.L-1. The precision was good. The recoveries of the six organic solvents ranged from 97% to 105% (RSD <4%). Conclusion The method is sensitive, accurate and reliable and suitable for the detection of organic solvent residues in the candidate new drug SM934 quality control.