摘要
目的:研究建立测定药物中N,N-二甲基甲酰胺(DMF)残留量和方法。方法:采用气相色谱法,以10％PEG20M和2％KOH为固定相,以N,N-二甲基乙酰胺为内标物。结果:实验证明,DMF与内标物分离良好,浓度在9.44～188.8μg/ml范围内与峰面积呈线性关系,r=0.9999。平均加样回收率为101.3％,RSD0.48％。本方法最低检测限量为10ng。结论:本方法简便、准确、重现性良好,适用于药物中DMF残留量的测定。
OBJECTIVE:The aim is to study and set up a method of determining the residue of N,N -dimetheylformamide in drugs. METHOD:Gas chromatography was used for determination. Stable phase was 10% PEG 20M and 2% KOH. Internal standard was N,N-dimethylacetamide. The linear relationship was good in the range of 9. 44-188. 8μg/ml(r = 0. 9999). The average recovery was 101. 3% with a RSD of 0. 48%. The minimal detection limit was 10ng. CONCLUSION:This method could be used in the determination of the residue of N,N - dimethylformamide in drugs.
出处
《药学与临床研究》
1999年第4期17-18,共2页
Pharmaceutical and Clinical Research
