HPLC-RID法测定鲨肝醇相关物质  

HPLC-RID Method for the Determination of Batiolum Related Substances

作　　者：王德祥 WANG Dexiang(Changzhou Yabang Pharmaceutical Co.,Ltd.,Changzhou 213200,China)

机构地区：[1]常州亚邦制药有限公司,江苏常州213200

出　　处：《生物化工》2024年第5期142-145,共4页Biological Chemical Engineering

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2.0188~20.1877μg/mL范围内,线性方程y=611.0773x+61.0474,相关系数r=0.9998;杂质Ⅰ在2.1348~21.3484μg/mL范围内,线性方程y=592.1590x+37.0076,相关系数r=0.9996;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。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 2.0188 to 20.1877μg/mL,the linear equation is y=611.0773x+61.0474,the correlation coefficient r=0.9998;the impurity I in the range of 2.1348 to 21.3484μg/mL,the linear equation is y=592.1590x+37.0076,the correlation coefficient r=0.9996;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 

分 类 号：O657.72[理学—分析化学]