摘要
目的:分析低聚糖类药物成品中残留物N,N-二甲基甲酰胺(DMF)。方法:应用气相色谱法。结果:在FFAP(50m×0.32mm)色谱柱上,DMF与其它组分具有较好的分离效果,分离度〉1.5;DMF浓度在3.58~0.000358mg/mL范围内呈现良好的线性关系,r=0.9999;方法的检测限为1.0mg/mL;对同一试样的5次平行测定的相对标准偏差RSD为1.52%;该法的回收率达95.7%~98.4%。结论:该法操作简单、快速、准确性高、重复性好。
AIM : The quantitative determination of N,N-dimethylf in olgosaccharide was carried out. METHODS: Gas Chromatographic was employed. RESULTS: Experimental results showed that a good separation of DMF with other contents of sample was achieved on FFAP(50 m×0.32 mm) column, and the separation degree was more than 1.5. The linear range was 3.58 ~ 0. 000358 mg/mL with r = 0. 999 9 and the relative standard deviation was 1.52% ( n = 5 ). and the limit of detection was 1.0 mg/mL. The recovery of the method was in the range of 95.7%~98.4%. CONCLUSION: The method is simple, rapid,accurate and precise.
出处
《中成药》
CAS
CSCD
北大核心
2006年第5期703-704,共2页
Chinese Traditional Patent Medicine