高效液相色谱法测定2-甲基-5-硝基咪唑有关物质的研究
Study on the Determination of Related Substances of 2-Methyl-5-nitroimidazole by High Performance Liquid Chromatography
汤晓琴 1魏翔 2杨阳 3刘怀周 4侯鹏5
作者信息
- 1. 西安万隆制药股份有限公司,陕西西安 710119
- 2. 陕西军兴生物医药科技有限公司,陕西西安 710200;西安大兴医院,陕西西安 710016
- 3. 陕西格林维泽环保技术服务有限公司,陕西西安 710061
- 4. 西安市卫生学校,陕西西安 710000
- 5. 浙江华海药业股份有限公司,浙江临海 317024
- 折叠
摘要
建立了一种高效液相色谱法测定2-甲基-5-硝基咪唑中咪唑、2-甲基咪唑、5-硝基咪唑-2-甲酸、4(5)-硝基咪唑、2-硝基咪唑、2-甲基-1,4-二硝基咪唑等6种有关物质含量.采用五氟苯基硅烷键合硅胶填充剂色谱柱(PFPP-120,4.6 mm×250 mm,5 µm),柱温25℃,检测波长220 nm,流速1.0 mL/min.结果表明:各杂质线性关系良好,相关系数为0.999 3～1.000,定量限为0.013 7～0.082 9 μg/mL,重复性RSD为0.55％～1.86％,加标回收率为98.93％～100.43％,方法精密度、准确度、耐用性均符合要求,适用于2-甲基-5-硝基咪唑中有关物质的含量测定与质量控制.
Abstract
A high-performance liquid chromatography method was established to determine the content of 4(5)-nitroimidazole,imidazole and other related substances in 2-methyl-5-nitroimidazole.The experiment used a pentafluorophenylsilane bonded silica gel filling column(PFPP-120,4.6 mm × 250 mm,5 μm),with a column temperature of 25 ℃,detection wavelength of 220 nm and a flow rate of 1.0 mL/min.The results show that the linear relationship between various impurities is good,with a correlation efficiency of 0.999 3～1.000 and a quantification limit of 0.013 7～0.082 9 μg/mL,repeatability RSD value 0.55％～1.86％,and a spiked recovery rate at 98.93％～100.43％.The precision,accuracy,and durability of the method d are suitable for the content determination and quality control of related substances in 2-methyl-5-nitroimidazole.
关键词
高效液相色谱法/2-甲基-5-硝基咪唑/咪唑/有关物质/含量Key words
high performance liquid chromatography/2-methyl-5-nitroimidazole/imidazole/related substances/content引用本文复制引用
出版年
2024
NETL
NSTL
万方数据