摘要
建立盐酸格拉司琼原料中多种有机溶剂残留量的分离测定方法。采用顶空气相色谱法，载气为氮气，FID检测器，色谱柱为HP-1毛细管柱，程序升温，外标法测定盐酸格拉司琼中甲醇、异丙醇、乙醚、二氯甲烷、氯仿、四氢呋喃、二甲基甲酰胺、甲苯的残留量。8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0．9988～0．9997，平均回收率为93．5％～103．1％，精密度RSD均小于10％，检测限为0．0031．15μg·ml^-1。本方法快速、灵敏、准确，适用于盐酸格拉司琼中多种有机溶剂残留量的测定。
A headspace gas chromatography method for separating and determining various kinds of residual organic solvents in granisetron hydrochloride was established. A HP- 1 capillary column was used with nitrogen gas as carrier and FID as detector. The organic residuals including methanol, isopropanol, ethyl ether, dichloromethane, chloroform, tetrahydrofuran, N, N-dimethylformamide and toluene were separated and determined. There was good linearity （r = 0. 9988-0. 9997）. The average recovery rates were within the range of 93.5% and 103.1% and each RSD was less than 10%. The detection limits were within 0. 003% 1.15μg · ml^-1. The method was rapid, sensitive and accurate. It could be used for the determination of various organic residuals in granisetron hydrochloride.
出处
《中国药事》
CAS
2006年第8期484-485,510,共3页
Chinese Pharmaceutical Affairs
关键词
盐酸格拉司琼
有机溶剂残留量
顶空气相色谱法
Granisetron Hydrochlorofome
residual solvent
headspace gas chromatography
