摘要
Abstract
OBJECTIVE:To establish the method for residual organic solvents in stiripentol crude drug,such as ethanol,dichlormethane,n-hexane,acetic ether and isopropanol.METHODS:Capillary gas chromatography was used.The determination condition was as follows:(5％) phenyl-(95％) methylpolysiloxane as fixation fluid; InertCap 5MS/NP capillary column at 30 ℃ for 6 min,increased to 180℃ with rate of 50 ℃/min,maintaining 10 min; flame ionization detector with the temperature of 250 ℃ ;high purity nitrogen as carrier gas; headspace sampling,heating temperature of 90 ℃,heating time of 35 min.RESULTS:The r in linear ranges of ethanol,dichlormethane,n-hexane,acetic ether and isopropanol were 0.999 6-0.999 8; average recovery rates were 99.9％-100.3％ (RSD=0.99％-2.01％,n=3) ; the limits of quantitation were 0.145,0.176,0.089,0.448 and 0.445 ng,respectively; only the isopropanol was detected in 3 batches of samples.CONCLUSIONS:The established method is simple and accurate,and it can be used for the control of 5 residual solvents in stiripentol crude drug.关键词
司替戊醇/原料药/有机溶剂/残留量/毛细管气相色谱法/测定Key words
Stiripentol/ Crude drug/ Organic solvents/ Residual/ Capillary GC/ Determination分类
医药卫生
