HPLC-RID法测定鲨肝醇相关物质
HPLC-RID Method for the Determination of Batiolum Related Substances
王德祥1
作者信息
- 1. 常州亚邦制药有限公司,江苏 常州 213200
- 折叠
摘要
目的:建立鲨肝醇有关物质检查的方法.方法:采用高效液相色谱-示差折光检测器(HPLC-RID),以甲醇-乙腈(体积比 20∶80)为流动相,流速为 1.0 mL/min,检测器温度和柱温为 35℃.结果:方法专属性良好,鲨肝醇在 2.018 8～20.187 7 μg/mL范围内,线性方程y=611.077 3x+61.047 4,相关系数r=0.999 8;杂质Ⅰ在 2.134 8～21.348 4 μg/mL范围内,线性方程y=592.159 0x+37.007 6,相关系数r=0.999 6;平均加标回收率在94.4%～95.9%,RSD小于1.5%.结论:本方法准确、可靠,可用于鲨肝醇有关物质的研究.
Abstract
Objective:To establish a method for the detection of batiolum related substances.Methods:High performance liquid chromatography-refractive index detector(HPLC-RID)is used with methanol-acetonitrile(volume ratio of 20 to 80)as mobile phase,the flow rate is 1.0 mL/min,and the detector temperature and column temperature are 35℃.Results:The specificity of the method is good,batiolum in the range of 2.018 8 to 20.187 7 μg/mL,the linear equation is y=611.077 3x+61.047 4,the correlation coefficient r=0.999 8;the impurity Ⅰ in the range of 2.134 8 to 21.348 4 μg/mL,the linear equation is y=592.159 0x+37.007 6,the correlation coefficient r=0.999 6;the average recovery rate is 94.4％to 95.9％,RSD is less than 1.5％.Conclusion:This method is accurate and reliable,and can be used for the research of batiolum-related substances.
关键词
鲨肝醇/有关物质/高效液相色谱-示差折光检测器Key words
batiolum/related substances/HPLC-RID引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据