顶空气相色谱法测定盐酸表柔比星中九种残留溶剂的含量

Determination of nine solvent residues in epirubicin hydrochloride by head-space gas chromatography

建立了顶空气相色谱法测定盐酸表柔比星中的残留溶剂含量的方法。采用DB-17MS弹性毛细管色谱柱(30m×0.53mm×3.0μm),氢火焰离子化检测器(FID),程序升温进行测定。9种残留溶剂均完全分离,在考察的浓度范围内线性关系良好(r大于0.999),回收率符合规定。该气相色谱方法准确,灵敏度高,可用于盐酸表柔比星中残留溶剂的质量控制。

A method to determine solvent residues in epirubicin hydrochloric by head-space gas chromatography was establised A DB-17 MS capillary column （30m×0. 53mm, 30μm） was used for separation with nitrogen as carrier gas, and a flame ionization detector for detection. Column temperature was programmed. The column oven was maintained at 40℃ for 5 min, then raised to 220℃ at 10°/min and maintained for 2min. Nine solvent residues were separated completely. The linearities were good in the concentration ranges （r〉0. 999）, and the coveries were from 99.3% to 100.8%. The method is accurate and sensitive.