气相色谱法测定伊潘立酮中丙酮、乙醇等多溶剂残留量

GC determination of 6 kinds of residual solvents in Iloperidone

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：采蹋DB．1701（30m×0．32mm×1．0um）毛细管柱，程序升温：60℃保持1min，然后以6℃，rn{n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O．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刹同时测定.

To establish a method for determi,：ation of the residues of 6 kinds of solvents in Iloperidone by caplillary gas chromatography. Method： The six organic solvents were separated on a DB-1701（30mx0.32mmx 1.01am） using programmable increased temperature. The column temperature is initially maintained at 60℃ for 1 rain and then up to 83℃ at the rate of 6 ℃/min for 8 rain, and eventually raised to 240℃ at the rate of 20℃/min for 5 rain. The samples were dissolved in DMSO with 1butanol as the reference, and the relative adjustment retention time （RART） was applied to manipulate the qualitative analysis. Results： Each solvent was completely separated and excellent linearity and recov eries were obtained. The average recoveries were 92.02% to 107.83% with Coefficient of variation from 0.40% to 4.56%. Conclusion： The method is simple, accurate and sensitive. It can be used to determine the residual solvents in Iloperidone.