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高效液相色谱法测定芦荟大黄素的有关物质

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目的 建立HPLC法测定芦荟大黄素中有关物质的含量.方法 采用HPLC法分析,色谱柱为Welch Xtimate C18(150 mm×4.6 mm,5 μm)柱;以pH 2.0磷酸盐缓冲液-甲醇-乙腈为流动相,梯度洗脱;流速为1.2mL·min-1,进样量为20 μL,柱温为30℃,检测波长为254 nm.结果 芦荟大黄素与其有关物质的色谱峰均能良好分离,精密度试验表明,当杂质含量<0.1%,12份样品的RSD<13%;当杂质含量≥0.1%,12份样品的RSD<4.0%,方法精密度良好.同一厂家6批芦荟大黄素样品测定结果显示,最大单杂为已知杂质大黄醛,含量1.42%,杂质总含量小于5.0%,但不同批样品间杂质存在差异.结论 建立的方法灵敏、专属性强,准确度高,可用于芦荟大黄素有关物质的测定.
Determination of aloe-emodin related substances by HPLC
Objective To determine the related substances in aloe-emodin by HPLC.Methods A Welch Xtimate C18 column(150 mm × 4.6 mm,5 μm)was used with a mobile phase consisted of pH 2.0 phosphate buffer-methanol-acetonitrile in the gradient elution.The flow rate was maintained at 1.2 mL·min-1,with an injection volume of 20 μL,a column temperature of 30 ℃,and detection wavelength at 254 nm.Results Aloe-emodin and its related substances were well separated.Experiments revealed excellent precision,with a maximum relative standard deviation(RSD)below 13%when the impurity content was below 0.1%.When the impurity content≥0.1%,the maximum RSD among the 12 parts tested was below 4.0%.The predominant single impurity as rhubarb aldehyde was identified in 6 batches of aloe-emodin samples from the same manufacturer,with a content of 1.42%.The total impurity content in these samples was less than 5.0%,with variations in the impurity profiles among different batches.Conclusion This method is sensitive,specific,and accurate,which is suitable for the detection of related substances in aloe-emodin and control its quality.

aloe-emodinHPLCmuti-component content determinationquality control

姚倩、邓远雄、李岩、罗剑、夏志强、杜乐

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湖南师范大学医学院,长沙 410013

长沙晶易医药科技股份有限公司,长沙 410013

鄂尔多斯市中心医院药剂科,内蒙古 鄂尔多斯 017000

芦荟大黄素 高效液相色谱 多组分含量测定 质量控制

湖南省自然科学基金

2020JJ4437

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(4)
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