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目的 :建立毛细管气相色谱法测定伊潘立酮中6种有机残留溶剂的方法。方法 :采用DB-1701(30m×0.32mm×1.0μm)毛细管柱,程序升温:60℃保持1min,然后以6℃/min的升温速率升至83℃,保持8min,再以20℃/min的升温速率升至240℃,保持5min。以DMSO为溶剂,正丁醇为参比物,用校正相对保留时间(RART)定性。结果 :各溶剂能得到较好的分离,精密度、线性关系良好,6种溶剂的平均回收率范围为92.02%~107.83%,RSD值为0.40%~4.56%。结论:本方法简便、准确、灵敏,适合用于伊潘立酮中多种残留溶剂同时测定。
Objective: To establish a method for the determination of six organic residual solvents in iloperidone by capillary gas chromatography. Methods: A capillary column with DB-1701 (30m × 0.32mm × 1.0μm) was used. The program temperature was raised at 60 ℃ for 1min and then increased to 83 ℃ at a rate of 6 ℃ / min for 8min. The heating rate was raised to 240 ° C for 5 min. DMSO as a solvent, n-butanol as a reference, with the relative retention time corrected (RART) Qualitative. Results: The solvents could be separated well with good linearity. The average recoveries of the six solvents ranged from 92.02% to 107.83% with RSD values of 0.40% -4.56%. Conclusion: The method is simple, accurate and sensitive and suitable for the simultaneous determination of various residual solvents in iloperidone.