顶空进样-毛细管气相色谱法测定伊潘立酮原料药中的溶剂残留

Determination of residue organic solvent in crude drug of IIoperidone by headspace-capillary gas chromatography

目的建立测定伊潘立酮原料药有机残留溶剂的顶空气相色谱法。方法采用顶空进样毛细管气相色谱法测定,色谱柱为DB-FFAP石英毛细管色谱柱(25m×320μm×3μm)。氮气为载气,测定伊潘立酮原料药中丙酮、乙醇与石油醚的残留量。结果 3种溶剂完全分离,在所考察的浓度范围内线性关系良好。伊潘立酮原料药中丙酮和石油醚的残留量的平均值分别为0.0371%、0.0291%,未检出乙醇。结论该方法简便、结果准确,适用于伊潘立酮原料药中有机残留溶剂的测定。

Objective To determin organic solvent residual volume in IIoperidone raw material by headspace gas chromatography. Methods The residual organic, solvents including acetone, ethanol and petroleumether were quantitatively determined by headspace gas chromatography method.A column DB-FFAP（25m×320μm×3μmwas adopted.N2 was the carrier gas. Results Three residual organic solvents were completely separated.The residues of solvents in Iloperidone were determined as follow,acetone was 0.0371% and petroleumether was 0.0291%,ethanol was not determined. Conclusion The method is simple,sensitive,accurate and be used for the quality control of Iloperidone.