盐酸纳洛酮中有机溶剂残留量的毛细管GC测定

Determination of Residual Organic Solvents in Naloxone Hydrochloride by Capillary GC

建立盐酸纳洛酮原料中多种有机溶剂残留量的分离测定方法。采用气相色谱法,载气为氮气,FID检测器,色谱柱为HP-50毛细管柱,程序升温,外标法测定盐酸纳洛酮中乙醇、丙酮、二氯甲烷、乙酸乙酯、甲苯的残留量。5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0.9998～0.9999,平均回收率为96.6%～101.9%,精密度RSD均小于10%,检测限为0.10～0.19μg·mL-1。本方法快速、灵敏、准确,适用于盐酸纳洛酮中多种有机溶剂残留量的测定。

A method for determination of five residual organic solvents in naloxone hydrochloride was established. The residual solvents in naloxone hydrochloride are ethanol, acetone, chloromethane, ethyl acetate, toluene which were quantitatively determined by GC on HP-50 column, with FID detector, nitrogen as the carries. Five residual solvents were completely separated. There was a good linearity （r=0. 9998～0. 9999）. The RSD of precision was less than 10%. The average recovery rate was in the range of 96.6～101.9%. The detection limits was between 0.10～0.19gμ·mL^-1. The method is rapid, sensitive and accurate. It is suitable for the measurement of residual solvents in naloxone hydrochloride.