顶空气相色谱法测定盐酸利托君中有机溶剂残留量

Determination of Residual Organic Volatile in Ritodrine Hydrochloride by Headspace Gas Chromatography

建立盐酸利托君原料中有机溶剂残留量的分离测定方法。采用顶空气相色谱法，载气为氮气，FID检测器，色谱柱为HP—INNOWax毛细管柱，流速为2．0mL·min^-1，外标法测定盐酸利托君中丙酮、乙酸乙酯、甲醇的残留量。3种有机溶剂完全分离，在所考察的浓度范围内具有良好的线性，r为0．9992～0．9997．平均回收率为95．7％～102．1％，精密度RSD均小于10％，检测限为0．21～2．02μg·mL^-1。本方法快速、灵敏、准确，适用于盐酸利托君中有机溶剂残留量的测定。

To establish a method for determination of three residual organic solvents in ritodrine hydroehloride. The residual solvents in ritodrine hydroehloride, which are aeeton, ethylacetate and methanol, were quantitatively determined by headspaee GC on HP-INNOWax column, with FID detector, nitrogen as the carries. Three residual solvents were completely separated. There was a good linearity （r： 0. 9992～0. 9997）. The RSD of precision was less than 10%. The average recovery rate was in the range of 95.7～102. 1%. The detection limits was between 0.21～2.02μg 0 mL-1. The method is rapid, sensitive and accurate, and can be used for quality control for the drug concerned.