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目的建立顶空气相色谱法测定咪唑斯汀原料药中5种溶剂的残留量。方法采用顶空毛细管气相色谱法,色谱柱:Agilent DB-624(30 m×0.25 mm,1.4μm),柱温:程序升温,检测器:氢火焰离子化检测器,载气:氮气,顶空平衡温度:80℃,平衡时间:30 min,顶空定量环体积:1 mL,定量环温度:90℃,传输线温度:100℃。结果 5种溶剂均获得基线分离,在考查的浓度范围内线性关系良好(r≥0.999 0),平均回收率94.0%~102.9%(w)。结论该方法可用于咪唑斯汀原料药中溶剂残留量的检查。
Objective To establish a headspace gas chromatographic method for the determination of the residues of five solvents in mizolastine. Methods The capillary GC method was used. The column was Agilent DB-624 (30 m × 0.25 mm, 1.4 μm). The column temperature was programmed and the detector was hydrogen flame ionization detector. The carrier gas was nitrogen gas, Equilibrium temperature: 80 ° C, equilibration time: 30 min, headspace loop volume: 1 mL, loop temperature: 90 ° C, transfer line temperature: 100 ° C. Results All the five solvents were baseline separated and had good linearity (r≥0.999 0) with the average recoveries of 94.0% -102.9% (w). Conclusion This method can be used for the determination of solvent residues in mizolastine APIs.