Chinese Journal of Pharmaceutical Analysis >

2024 , Vol. 44 >Issue 3: 386 - 394

DOI: https://doi.org/10.16155/j.0254-1793.2024.03.03

Ingredient Analysis

Study on UPLC fingerprint and quantitative analysis of multi-components by single marker of Qiye Shen'an dropping pills*

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  • 1. Beijing Institute for Drug Control, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing 102206, China;
    2. Waters Technologies Beijing Limited, Beijing 101111, China;
    3. Jinqi Pharmaceutical Co., Ltd., Yunnan 663100, China

Received date: 2024-02-26

  Online published: 2024-06-21

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Abstract

Objective: To establish the ultra high performance liquid chromatography (UPLC) fingerprint of Qiye Shen'an dropping pills, and to determine the contents of 8 index components by quantitative analysis of multi-components by single marker at the same time. Methods: Waters CORTECS® T3 (150 mm×2.1 mm, 1.6 μm) chromatography column was used for gradient elution with acetonitrile-0.1% phosphoric acid as mobile phase, flow rate was 0.40 mL·min-1, column temperature was 35 ℃, detection wavelength was 203 nm. Results: The UPLC fingerprint of Qiye Shen'an dropping pills was established, 8 common peaks were established, and the similarity of 15 batches of samples was greater than 0.99. Ginsenoside Rb1, ginsenoside RC, panax notoginseng saponin FC, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rd, panax notoginseng saponin Fe and panax notoginseng saponin Fd were determined by quantitative analysis of multi-components by single marker method. The contents of 8 components in 15 batches were between 7.6-10.0 mg per pill. The average recoveries were 99.8%, 100.6%, 99.8%, 101.2%, 102.1%, 101.9%, 99.7% and 100.2% respectively, and the RSDs were 2.3%, 2.2%, 2.0%, 1.5%, 1.7%, 1.2%, 2.4% and 2.6% respectively. Conclusion: The UPLC fingerprint of Qiye Shen'an dropping pills and the content determination method of quantitative analysis of multi-components by single marker method established in this study are simple to operation, and have good repeatability, stability and reliability, and can provide a more comprehensive basis for the quality control of Qiye Shen'an dropping pills.

Key words： Qiye Shen'an dropping pills; total saponins from panaxnotpginseng stem and leaf; ginsenoside; panax notoginseng saponin; UPLC; fingerprint; quantitative analysis of multi-components by single marker; quality control

Cite this article

WANG Jing-hui, YU Mi-mi, Chen Jing, WANG An-qi, FANG Shuang, CHEN You-gen, ZHANG Yun-sheng, FU Xin-tong, GUO Hong-zhu . Study on UPLC fingerprint and quantitative analysis of multi-components by single marker of Qiye Shen'an dropping pills*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(3) : 386 -394 . DOI: 10.16155/j.0254-1793.2024.03.03

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