CAJ | 학술논문

目的：采用气相色谱法测定磷酸二甲啡烷原料药中的乙酸乙酯、三氯甲烷和N,N-二甲基甲酰胺(DMF)3种有机溶剂的残留量。方法：采用毛细管气相色谱法,PEG-20M柱,程序升温,以水为溶剂,FID检测器,对乙酸乙酯、三氯甲烷和DMF的残留量进行检测。结果：3种有机溶剂基本实现基线分离且线性关系良好(r均在0.9990以上),上述3种溶剂残留的检出限范围分别为0.63,0.60和8.92μg·ml-1。3批样品中3种有机溶剂的残留量均符合ICH的规定。结论：该检测方法灵敏、准确、可靠,可用于磷酸二甲啡烷原料的质量控制。
목적：채용기상색보법측정린산이갑배완원료약중적을산을지、삼록갑완화N,N-이갑기갑선알(DMF)3충유궤용제적잔류량。방법：채용모세관기상색보법,PEG-20M주,정서승온,이수위용제,FID검측기,대을산을지、삼록갑완화DMF적잔류량진행검측。결과：3충유궤용제기본실현기선분리차선성관계량호(r균재0.9990이상),상술3충용제잔류적검출한범위분별위0.63,0.60화8.92μg·ml-1。3비양품중3충유궤용제적잔류량균부합ICH적규정。결론：해검측방법령민、준학、가고,가용우린산이갑배완원료적질량공제。
Objective:To determine the content of chloroform, ethyl acetate and DMF in dimemorfan phosphate by gas chromatog-raphy (GC). Methods:The capillary gas chromatography was used with a PEG-20M column, programmed temperature, water as the solvent and FID as the detector. Results:The three organic solvents were separated and showed good linear relationship (r>0. 999 0). The detection limit of chloroform, ethyl acetate and DMF was 0. 63,0. 60 and 8. 92μg·ml-1 , respectively. The residues of the organ-ic solvents in three batches of the samples all met with the requirements of ICH. Conclusion: The method is sensitive, accurate and reliable, and can be used in the quality control of dimemorfan phosphate.