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超高效液相色谱串联质谱法同时检测更年期用中成药中7种雌激素及孕激素

霍甜甜 李宜鲜 申二永 王海波

中国药业2025,Vol.34Issue(22):85-89,5.
中国药业2025,Vol.34Issue(22):85-89,5.DOI:10.3969/j.issn.1006-4931.2025.22.018

超高效液相色谱串联质谱法同时检测更年期用中成药中7种雌激素及孕激素

Simultaneous Determination of Seven Estrogens and Progestogens in Chinese Patent Medicines for Menopause-Treating by UPLC-MS/MS

霍甜甜 1李宜鲜 1申二永 1王海波1

作者信息

  • 1. 河南省药品医疗器械检验院·河南省疫苗批签中心,河南 郑州 450009
  • 折叠

摘要

Abstract

Objective To establish an ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method for simultaneous detection of seven estrogens and progestins in Chinese patent medicines for menopause-treating.Methods The chromatographic column was the Waters Acquity UPLC BEH-C18 column(100 mm×2.1 mm,1.7 µm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 30℃,and the injection volume was 5 µL.The electrospray ionization(ESI)source was operated,with ionization modes of ESI-(diethylstilbestrol and estradiol),and ESI+(gestrinone,norgestrel,medroxyprogesterone acetate,chlormadinone acetate,and progesterone).The multiple reaction monitoring(MRM)was used.The capillary voltage was 3.0 kV,the ion source temperature was 150℃,the desolvation gas temperature was 500℃,the desolvation gas flow was 1 000 L/h,and the cone gas flow was 50 L/h.Results The linear ranges of diethylstilbestrol,estradiol,gestrinone,norgestrel,medroxyprogesterone acetate,chlormadinone acetate,progesterone were 6.209-206.960 ng/mL,6.321-210.704 ng/mL,5.720-224.325 ng/mL,5.327-190.649 ng/mL,5.040-171.312 ng/mL,6.496-168.000 ng/mL,7.026-216.548 ng/mL(r≥0.996,n=6),respectively.The RSDs of precision,stability,and repeatability tests were all lower than 5.0%.The average extraction recoveries were 104.38%,97.29%,98.66%,106.33%,92.77%,92.25%,90.07%,with RSDs of 3.97%,6.42%,5.63%,4.16%,3.28%,1.96%,3.11%(n=9),respectively.The analysis revealed no detection of the seven target estrogen and progestins in any of the samples.Conclusion The established method is simple,reliable,and suitable for the simultaneous determination of seven estrogens and progestogens in Chinese patent medicines for menopause-treating.

关键词

超高效液相色谱串联质谱法/中成药/雌激素/孕激素

Key words

UPLC-MS/MS/Chinese patent medicine/estrogen/progestogen

分类

医药卫生

引用本文复制引用

霍甜甜,李宜鲜,申二永,王海波..超高效液相色谱串联质谱法同时检测更年期用中成药中7种雌激素及孕激素[J].中国药业,2025,34(22):85-89,5.

基金项目

河南省市场监督管理局科技计划项目[2023sj61]. ()

中国药业

1006-4931

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