目的建立顶空气相色谱法测定氯沙坦钾原料药有机残留溶剂的方法。方法选用Agilent 7890气相色谱仪,配备7697顶空进样器,DB-624毛细管色谱柱作为分析柱,FID检测器,外标法测定;并对分析方法建立进行研究。结果甲醇、异丙醇、乙酸乙酯、环己烷、甲苯分别在0.122~90.2,0.28~151.3,0.03~61.4,0.22~76.4,0.035~26.8μg·mL~(-1)线性关系良好(r>0.999);各组分检测限分别为0.037,0.090,0.009,0.070,0.012μg·mL~(-1);各组分平均回收率为90.0%~110.0%。结论该方法简单、可靠、准确,可用于原料药氯沙坦钾有机残留溶剂的测定。 OBJECTIVE To establish a method for the determination of losartan potassium in organic residual solvents by headspace gas chromatography. Methods Agilent 7890 gas chromatograph was equipped with 7697 headspace sampler, DB-624 capillary column as analytical column, FID detector and external standard method. The establishment of analytical methods was also studied. Results The linear relationship between methanol, isopropanol, ethyl acetate, cyclohexane and toluene was good at 0.122 ~ 90.2,0.28 ~ 151.3,0.03 ~ 61.4,0.22 ~ 76.4,0.035 ~ 26.8μg · mL ~ (-1) > 0.999). The detection limits of each component were 0.037,0.090,0.009,0.070 and 0.012μg · mL -1, respectively. The average recoveries of each component ranged from 90.0% to 110.0%. Conclusion The method is simple, reliable and accurate and can be used for the determination of losartan potassium organic residual solvents.