摘要
建立了一种高效液相分析方法可用于1-脱氧野尻霉素，葡萄糖和葡萄糖胺的杂质分析。该方法以乙腈／水酸性系统为流动相体系，色谱柱采用Waters Atlantis HILIC Silica（5μm，150×4．6mm），以蒸发光散射检测器（ELSD）进行检测，采用主成分自身对照法用于杂质含量的计算。方法验证结果表明，1．脱氧野尻霉素，葡萄糖和葡萄糖胺在0．008—0．04mg／mL范围内峰面积对质量浓度呈现良好的线性，线性回归系数分别为0．9993，0．9998，0．9996。1．脱氧野尻霉素，葡萄糖和葡萄糖胺的最低检测浓度分别为0．0045，0．0040，0．0039mg／mL。3种化合物在0．02，0．04，0．08mg／mL3种质量浓度点的重现性良好，RSD％均小于10％。
A high performance liquid chromatographic method was developed for impurity test of 1-deoxynojirimycin, glucose and glucosamine. Acetonitrile and water containing trifluoroacetic acid are used as mobile phase in this method and column is Waters Atlantis HILIC Silica （5μm, 150 × 4.6 mm）. ELSD is used for determination and impurity content is calculated by high-low analysis. Results of method validation showed that the method had good linear correlation between the peak areas and concentrations of 1-deoxynojirimycin, glucose and glucosamine （0.008- 0.04 mg/mL）. The correlation coefficients are 0.9993, 0.9998, 0. 9996 for 1-deoxynojirimycin, glucose and glucosamine respectively. The limits of detection of 1-deoxynojirimycin, glucose and glucosamine are 22.5, 20.0, 19.6 ng, respectively. The reproducibilities at 0.02, 0.04, 0.08 mg/mL are good （RSD% 〈 10% ）. This HPLE-ELSD method can be used for impurity determination of 1-deoxynojirimycin, glucose and glucosamine.
出处
《分析试验室》
CAS
CSCD
北大核心
2007年第7期83-86,共4页
Chinese Journal of Analysis Laboratory
关键词
1-脱氧野尻霉素
葡萄糖
葡萄糖胺
高效液相色谱法
蒸发光散射检测
杂质分析
1-deoxynojirimycin
Glucose
Glucosamine
High performance liquid chromatography
Evaporative light scattering detector
Impurity test
