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HPLC-RID法测定鲨肝醇相关物质

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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.
HPLC-RID Method for the Determination of Batiolum Related Substances
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.

batiolumrelated substancesHPLC-RID

王德祥

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常州亚邦制药有限公司,江苏 常州 213200

鲨肝醇 有关物质 高效液相色谱-示差折光检测器

2024

生物化工

生物化工

ISSN:
年,卷(期):2024.10(5)