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目的:建立气相色谱法检测非那雄胺原料药中有机残留溶剂的方法。方法:色谱柱为HP-INNOWAX(30m×0.53mm,3.0μm),氢火焰离子化检测器,载气为氮气;进样口温度:220℃;检测器温度:240℃;程序升温:40℃保持5min,以10℃.min-1升温至220℃,保持2min。以N-甲基吡咯烷酮为溶剂,正丁醇为内标。结果:被测物均能达到较好的分离,峰面积与浓度呈良好的线性关系,精密度良好。结论:本法可用于非那雄胺原料药中有机溶剂残留量的检测。
Objective: To establish a gas chromatography method for the determination of residual organic solvents in finasteride drug substance. Methods: The chromatographic column was HP-INNOWAX (30m × 0.53mm, 3.0μm) with flame ionization detector and carrier gas was nitrogen. Inlet temperature was 220 ℃, detector temperature was 240 ℃, programmed temperature was 40 ℃ Hold 5min, with 10 ℃. Min-1 temperature was raised to 220 ℃, hold 2min. N-methylpyrrolidone as solvent, n-butanol as internal standard. Results: The analytes could achieve good separation, the peak area and concentration showed a good linear relationship, good precision. Conclusion: This method can be used for the determination of residual organic solvents in finasteride drug substance.