中国药业2024,Vol.33Issue(24) :74-77.DOI:10.3969/j.issn.1006-4931.2024.24.017

高效液相色谱法同时测定八味石灰华丸中2种成分含量

Simultaneous Determination of Two Components in Bawei Shihuihua Pills by HPLC

蔡缘缘 谢和兵 尼玛次仁 白玛旦增 袁志兵
中国药业2024,Vol.33Issue(24) :74-77.DOI:10.3969/j.issn.1006-4931.2024.24.017

高效液相色谱法同时测定八味石灰华丸中2种成分含量

Simultaneous Determination of Two Components in Bawei Shihuihua Pills by HPLC

蔡缘缘 1谢和兵 2尼玛次仁 3白玛旦增 3袁志兵1
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作者信息

  • 1. 安徽中医药大学药学院,安徽 合肥 230012;江苏省南通市海门长三角药物高等研究院,江苏南通 226133;江苏神猴医药研究有限公司,江苏 南通 226133
  • 2. 安徽中医药大学药学院,安徽 合肥 230012;江苏省南通市海门长三角药物高等研究院,江苏南通 226133;江苏神猴医药研究有限公司,江苏 南通 226133;西藏神猴药业有限责任公司,西藏 日喀则 857000
  • 3. 西藏神猴药业有限责任公司,西藏 日喀则 857000
  • 折叠

摘要

目的 建立同时测定八味石灰华丸中鞣花酸(EA)、羟基红花黄色素A(HYSA)含量的高效液相色谱(HPLC)法.方法 色谱柱为ZORBAX Eclipse Plus C18柱(250 mm × 4.6 mm,5 μm),流动相为0.1%磷酸水溶液-甲醇(梯度洗脱),流速为1.0mL/min,检测波长为253 nm(EA)、403 nm(HYSA),柱温为35℃,进样量为10 μL.结果 EA、HYSA质量浓度分别在0.73~14.52 μg/mL及3.97~79.45 μg/mL范围内与峰面积线性关系良好(r=0.999 8、1.0000,n=7);检测限分别为0.29 μg/mL及1.59 μg/mL,定量限分别为0.58 μg/mL及3.18 μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为103.36%及102.57%,RSD分别为3.00%及2.75%(n=6).结论 该方法操作简便、结果准确,可用于同时测定八味石灰华丸中EA、HYSA的含量.

Abstract

Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneous determination of ellagic acid(EA)and hydroxysafflor yellow A(HYSA)in Bawei Shihuihua Pills.Methods The chromatographic column was the ZORBAX Eclipse Plus C18 column(250 mm × 4.6 mm,5 μm),the mobile phase was 0.1%phosphoric acid aqueous solution-methanol(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths were 253 nm(EA)and 403 nm(HYSA),the column temperature was 35℃,and the injection volume was 10 μL.Results The linear ranges of EA and HYSA were 0.73-14.52 μg/mL,3.97-79.45 μg/mL(r=0.999 8,1.000 0,n=7)respectively.The limits of detection of EA and HYSA were 0.29 μg/mL,1.59 μg/mL,the limits of quantification were 0.58 μg/mL,3.18 μg/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of EA and HYSA were 103.36%,102.57%with RSDs of 3.00%,2.75%(n=6)respectively.Conclusion This method is easy and accurate,which can be used to simultaneously determine the contents of EA and HYSA in Bawei Shihuihua Pills.

关键词

藏药/八味石灰华丸/鞣花酸/羟基红花黄色素A/高效液相色谱法/含量测定

Key words

Tibetan medicine/Bawei Shihuihua Pills/ellagic acid/hydroxysafflor yellow A/HPLC/content determination

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出版年

2024
中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
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