Chinese Journal of Pharmaceutical Analysis >

2024 , Vol. 44 >Issue 9: 1560 - 1566

DOI: https://doi.org/10.16155/j.0254-1793.2024-0222

Standard Deliberation

Linear calibration with two reference substances for multi-component qualitative analysis of Radix Isatidis*

Expand
  • 1. Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China;
    2. Key Labratory of Quality Research and Evaluation of Traditional Chinese Medicines, State Medical Products Administration, Heilongjiang Provincial Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicines, Heilongjiang Institute for Drug Control, Harbin 150088, China;
    3. Harbin University of Commerce, Harbin 150028, China;
    4. National Institutes for Food and Drug Control, Beijing 100050, China

Received date: 2024-04-03

  Online published: 2024-10-17

Fold

Abstract

Objective: To establish an HPLC method for the simultaneous determination of six components (uridine, adenine, adenosine (R,S)-goitrine, guanosine,clemastanin B) in Radix Isatidis, and to investigate the linear calibration with two reference substances (LCTRS) method for the qualitative analysis of multiple components in Radix Isatidis. Methods: HPLC method was used, with methanol as mobile phase A and water as mobile phase B. Gradient elution (0-3 min, 3%A; 3-18 min, 3%A→14%A; 18-25 min, 14%A→26%A; 25-34 min, 26%A; 34-40 min, 26%A→46%A; 40-60 min, 46%A→90%A) was performed at a flow rate of 0.8 mL·min-1. The column temperature was 30 ℃, the detection wavelengths were 254 nm (0-32 min) and 230 nm (32-60 min). The injection volume was 10 μL. The actual retention time of 6 components in Radix Isatidis was determined on 13 C18 chromatographic columns of different brands and models. Guanosine and clemastanin B were used as double reference compounds, and LCTRS method was used to locate the chromatographic peak of each component. Three unknown chromatographic columns were used for method validation. Using guanosine as a reference substance, the relative retention time method was used to predict the retention time of the other 5 components. The predictive accuracy and column coincidence of these two methods were compared. Results: The LCTRS method could effectively predict and qualitatively analyze the retention time of six indicator components. Compared with the relative retention time method, the LCTRS method had higher accuracy in predicting results and better column universality. Conclusion: The LCTRS method for simultaneous determination of multiple components in Radix Isatidis is feasible and accurate, with simple operation and good durability, and has promotional value.

Key words： Radix Isatidis; linear calibration with two reference substances; guanosine; clemastanin B; uridine; adenine; (R,S)-goitrine; adenosine

Cite this article

LI Gao-yan, YANG Yi-di, YUAN He-fei, QU Fan-na, LI Hui-yong, SUN Lei, MA Shuang-cheng, BI Xue-yan . Linear calibration with two reference substances for multi-component qualitative analysis of Radix Isatidis*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(9) : 1560 -1566 . DOI: 10.16155/j.0254-1793.2024-0222

References

[1] 马双成, 王莹. 我国中药质量控制模式及思路研究进展十年回顾[J/OL]. 中国药学杂志 [2023-09-28]. http://140.143.170.254/kcms/detail/11.2162.R.20230104.2122.001.html
MA SC, WANG Y. Review on the research progress of traditional Chinese medicine quality control models and ideas in the past decade [J/OL]. Chin Pharm J [2023-09-28]. http://140.143.170.254/kcms/detail/11.2162.R.20230104.2122.001.html
[2] 王清君, 孙磊, 刘峰,等. 标准物质的发展和挑战与数字化新形式[J]. 中国药学杂志, 2016, 51(18):1537
WANG QJ, SUN L, LIU F,et al. Progress and challenges of reference standards and their new form: digital reference standards (DRS)[J]. Chin Pharm J, 2016, 51(18):1537
[3] 高楚倩, 李康, 张琳玉,等. 基于一测多评法的茯苓皮药材质量控制研究[J]. 中药材, 2023, 46 (9): 2240
GAO CQ,LI K,ZHANG LY, et al. Research on quality control of Poria cocos peel medicinal materials based on quantitative analysis single marker method[J]. J Chin Med Mater, 2023, 46 (9): 2240
[4] 李帆, 杨滢, 缑慧君,等. 一测多评法同时测定小儿感冒宁糖浆中8种成分的含量[J]. 中医药导报, 2023, 29(8):35
LI F, YANG Y, HOU HJ, et al. Simultaneous determination of eight constituents in Xiao'er Ganmaoning sirup by QAMS[J]. Guiding J Tradit Chin Med, 2023, 29(08):35
[5] 万鸣, 黄超, 陈树和,等. 替代对照品法同时测定茯苓中多种三萜酸类成分的含量[J]. 中国医院药学杂志, 2023, 43(3):265
WAN M, HUANG C, CHEN SH, et al. Simultaneous determination of triterpenoid acids in Poria cocos by substituting reference substance method[J]. Chin J Hosp Pharm, 2023, 43(3):265
[6] 曾芳, 魏长勇, 余敏灵. 替代对照品法测定复方甘草口服溶液中甘草苷和甘草酸含量[J]. 中国药业, 2020, 29(23):52
ZENG F, WEI CY, YU ML. Content determination of liquiritin and glycyrrhizic acid in the compound glycyrrhiza oral solution by substitute reference substance method [J]. China Pharm, 2020, 29(23):52
[7] 孙磊, 金红宇, 马双成. 一种新的HPLC色谱峰保留时间预测法—双标线性校正法[C]// 第十四届全国中药和天然药物学术研讨会论文摘要, 北京,2014:433
SUN L, JIN HY, MA SC. A new HPLC chromatographic peak retention time prediction method—linear calibration with two reference substances[C]// Abstract of the 14th National Symposium on Traditional Chinese Medicine and Natural Medicine, Beijing: 2014:433
[8] 张琳琳, 董婷, 陈碧莲,等. 双标线性校正法用于延胡索中5个生物碱的定性分析[J]. 药物分析杂志, 2023, 43(1):77
ZHANG LL, DONG T, CHEN BL, et al. Simultaneous qualitative analysis of five alkaloids in Corydalis Rhizoma by the method of linear calibration with two reference substances[J]. Chin J Pharm Anal, 2023, 43(1):77
[9] 张毅, 周洪旭, 孟大利,等. 双标线性校正法用于川黄芩的多成分定性分析[J]. 食品与药品, 2022, 24(6):487
ZHANG Y, ZHOU HX, MENG DL, et al. Multicomponent qualitative analysis of Scutellariae Amoenae Radix by linear calibration using two reference substances [J]. Food Drug, 2022, 24(6):487
[10] 牛艳, 栾永福,许丽丽,等. 双标线性校正法用于槐角炭的指纹图谱研究[J]. 药物分析杂志,2022,42(9):1652
NIU Y, LUAN YF, XU LL, et al. Fingerprint analysis of Sophorae Fructus Carbonisata by linear calibration using two reference substances[J]. Chin J Pharm Anal, 2022, 42(9):1652
[11] 赵一擎, 张红伟, 王晓燕,等. 双标线性校正法用于一清颗粒的多指标成分定性分析[J]. 中国药学杂志, 2022, 57(12):1021
ZHAO YQ, ZHANG HW, WANG XY, et al. Determination of multiple components in Yiqing granules by linear calibration with two reference substances[J]. Chin Pharm J, 2022, 57(12):1021
[12] 栾永福, 刘洪超, 解盈盈, 等. 双标线性校正法用于盐沙苑子配方颗粒多组分定性分析 [J]. 药物分析杂志, 2023, 43 (11): 1876
LUAN YF, LIU HC, XIE YY, et al. Qualitative determination of multiple components in salted Astragali Complanati Semen dispensing granules by linear calibration using two reference substances[J]. Chin J Pharm Anal, 2023, 43 (11): 1876
[13] 纪国力, 周伟, 巴然然, 等. 双标多测法测定丹参配方颗粒中6个酚酸类成分 [J]. 药物分析杂志, 2023, 43 (8): 1326
JI GL, ZHOU W, BA RR, et al. Determination of 6 phenolic acids in Danshen formula granules by two reference substances for determination of multiple components method[J]. Chin J Pharm Anal, 2023, 43 (8): 1326
[14] 林燕翔, 黄博, 罗轶, 等. 基于双标多测法辅助HPLC的肿节风配方颗粒的多组分分析 [J]. 药物分析杂志, 2022, 42 (3): 402
LIN YX, HUANG B, LUO Y, et al. Multi-component analysis of Herba Sarcandrae dispensing granules based on TRSDMC assisted HPLC[J]. Chin J Pharm Anal, 2022, 42 (3): 402
[15] 付照羽, 冯治朋, 韩颜超,等. 板蓝根研究进展[J]. 现代农业科技, 2023(14):41
FU ZY, FENG ZP, HAN YC,et al. Research progress on Radix Isatidis [J]. Mod Agric Sci Technol, 2023(14):41
[16] 黄远, 董福越, 李楚源. 板蓝根中主要化学成分含量测定方法研究进展[J]. 中国药业, 2020, 29(7): 150
HUANG Y, DONG FY, LI CY. Research progress on the determination methods of main chemical components in Radix Isatidis[J]. China Pharm, 2020, 29(7): 150
[17] 邓九零, 陶玉龙, 何玉琼, 等. 板蓝根抗流感病毒活性成分及其作用机制研究进展 [J]. 中国中药杂志, 2021, 46 (8): 2029
DENG JL, TAO YL, HE YQ, et al. Research progress on active components and mechanism of Isatidis Radix for influenza virus [J]. China J Chin Mater Med, 2021, 46 (8): 2029
[18] 中华人民共和国药典2020年版. 一部[S]. 2020:214
ChP 2020. Vol Ⅰ[S]. 2020:214
[19] 孙磊, 金红宇, 逄瑜,等.双标多测法Ⅰ-双标线性校正技术用于色谱峰的定性[J]. 药物分析杂志, 2013, 33(8):1424
SUN L, JIN HY, PANG Y,et al. Two reference substances for determination of multiple components (Ⅰ): linear calibration using two reference substances for identification of chromatographic peaks[J]. Chin J Pharm Anal, 2013, 33(8):1424
Options
Outlines

/

〈 〉

京ICP备17052540号-4
Copyright © Chinese Journal of Pharmaceutical Analysis, All Rights Reserved.
E-mail：ywfx@nifdc.org.cn
Powered by Beijing Magtech Co. Ltd.