摘要
目的建立吡罗昔康原料药中有机溶剂残留量的气相色谱测定法。方法采用顶空气相色谱,使用HP-INNO-WAX毛细管色谱柱(30 m×0.32 mm×0.25μm);以高纯氮气为载气,FID为检测器,测定吡罗昔康原料药中甲醇、乙醇、甲苯及二甲苯4种有机溶剂的残留量。结果 4种有机溶剂均达到了完全分离,在所考察范围内线性关系良好。结论该方法灵敏度、准确度均达到有机溶剂残留量的检测要求,适用于吡罗昔康原料药中有机溶剂残留的检测。
Objective To establish a headspace capillary gas chromatgraphy for determination the residual organic solvents in piroxicam. Methods The residual solvents in piroxicam which are methanol , ethanol, toluene and dimethybenzene were determined by headspace GC on HP-INNOWax column（30m× 0.32mm×0.25μm） , with FID detector, high purity nitrogen as the carry gas. Results Four residual organic solvents consisting of methanol, ethanol, toluene and dimethybenzene in piroxicam were completely separated and the samples coincided with the requirements. Conclusion The method is sensitive and accurate. It is suitable to the determination of residual organic solvents in piroxieam.
出处
《药学实践杂志》
CAS
2011年第1期31-32,共2页
Journal of Pharmaceutical Practice
关键词
顶空气相色谱
吡罗昔康
有机溶剂残留
headspace gas chromatgraphy
piroxicam
residual organic solvents
