摘要
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 head space gas chromatography method for determination of residual solvents in active pharmaceutical ingredients of losartan potassium. METHODS Agilent 7890 gas chromatography with 7697 head space sampling and FID detector was selected. And DB-624 capillary column was used as analytical column. External standard method was used to determine the content. The analytical method was also explored. RESULTS A good linear correlation of methanol, isopropanol, ethyl acetate, cyclohexane and toluene were showed at the range of 0.122-90.2, 0.28-151.3, 0.03-61.4, 0.22-76.4 and 0.035-26.8 μg·mL^（-1） with r0.999, respectively. Detection limit of each components was 0.037, 0.090, 0.009, 0.070, 0.012 μg·mL^（-1）, respectively; Recovery range was 90.0%-110.0%. CONCLUSION The method is simple, reliable and accurate, can be used for determination of preservatives and sweeteners in oral liquid preparation.
出处
《中国现代应用药学》
CAS
CSCD
2017年第7期1015-1017,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
气相色谱法
顶空
原料药
氯沙坦钾
残留溶剂
gas chromatography
head space
active pharmaceutical ingredients
losartan potassium
residual solvents
