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高效液相一测多评法同时测定阴虚胃痛颗粒中8种成分含量
陈小存1, 魏谭军1, 陈飞1, 肖成1, 陈勇2
1.达州市中西医结合医院, 达州 635000;2.成都地奥集团天府药业有限公司, 达州 635027
摘要:
[目的] 建立高效液相一测多评(HPLC-QAMS)法同时测定阴虚胃痛颗粒中氧化芍药苷、芍药内酯苷、芍药苷、苯甲酰芍药苷、麦冬甲基黄烷酮A、甲基麦冬二氢高异黄酮B、法卡林二醇和人参炔醇的含量,建立该制剂多指标成分质量控制模式。[方法] 采用Agilent HC C18色谱柱;以乙腈-0.1%磷酸溶液为流动相,梯度洗脱;流速1.0 mL/min;柱温30℃;检测波长分别为230、296和254 nm;进样量10 μL。以芍药苷为内参物,建立其他7种成分的相对校正因子(RCF),并计算各成分含量。采用外标法(ESM)测定阴虚胃痛颗粒中8种成分含量,对一测多评法计算结果的准确性进行验证。[结果] 8种成分在各自范围内线性关系良好(r≥0.999 1);平均加样回收率及RSD分别为98.90%(1.01%)、100.02%(0.94%)、99.52%(0.76%)、97.88%(1.35%)、99.14%(1.42%)、96.85%(0.65%)、97.83%(0.92%)和98.65%(1.24%)。一测多评法所测结果与外标法无统计学差异。[结论] 该方法操作便捷、结果准确,可用于阴虚胃痛颗粒中8种成分含量的同时测定。
关键词:  阴虚胃痛颗粒  高效液相一测多评法  多指标成分  相对校正因子
DOI:10.11656/j.issn.1673-9043.2022.03.18
分类号:R284
基金项目:达州市重点研发计划项目(20ZDYF0007)。
Simultaneous determination of eight compounds in Yinxu Weitong Granules by HPLC-QAMS
CHEN Xiaocun1, WEI Tanjun1, CHEN Fei1, XIAO Cheng1, CHEN Yong2
1.Dazhou Hospital of Integrated Traditional Chinese and Western Medicine, Dazhou 635000, China;2.Chengdu Diao Group Tianfu Pharmaceutical Co. Ltd., Dazhou 635027, China
Abstract:
[Objective] To establish an HPLC-QAMS method for simultaneous determination of oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin, methylophiopogonanone A, methylophiopogonanone B, falcarindiol and panaxynol in Yinxu Weitong Granules, and to establish the multi-index components quality evaluation model for Yinxu Weitong Granules.[Methods] The Agilent HC C18 column was used, and the mobile phase consisted of acetonitrile-0.1% phosphoric acids solution with gradient elution, and the flow rate was 1.0 mL/min;The column temperature was 30℃;The detection wavelength were 230, 296 and 254 nm;The injection volume was 10 μL. With paeoniflorin as the internal reference, the relative correction factor(RCF) with other seven components was established, and the content of each component was calculated. The external standard method(ESM) was used to determine the contents of 8 components in Yinxu Weitong Granules to verify the accuracy of the calculation results of the QAMS.[Results] The 8 components have a good linear relationship within their respective ranges(r ≥ 0.999 1), whose average recoveries(RSD) were 98.90%(1.01%), 100.02%(0.94%), 99.52%(0.76%), 97.88%(1.35%), 99.14%(1.42%), 96.85%(0.65%), 97.83%(0.92%) and 98.65%(1.24%), respectively. There was no significant difference between HPLC-QAMS and ESM.[Conclusion] The established HPLC-QAMS method is convenient and accurate, which can be used for simultaneous determination of eight compounds in Yinxu Weitong Granules.
Key words:  Yinxu Weitong Granules  HPLC-QAMS  multi-index component  RCF
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