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Qualitative and quantitative assessment of related substances in baicalin eye drops
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Hong-fang ZHAO1, Yue CHEN1, Tao WU2, Ke-xin PAN2, Jun LU2, Qing LI1, *
Acta Pharmaceutica Sinica | 2025, 60(11) : 3483 - 3490
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Acta Pharmaceutica Sinica | 2025, 60(11): 3483-3490
• Original Articles •
Qualitative and quantitative assessment of related substances in baicalin eye drops
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Hong-fang ZHAO1, Yue CHEN1, Tao WU2, Ke-xin PAN2, Jun LU2, Qing LI1, *
Affiliations
  • 1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2Beijing Novelpharm Pharmaceutical Biotechnology Co., Ltd., Beijing 101102, China
Published: 2025-11-12 doi: 10.16438/j.0513-4870.2025-0437
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Baicalin eye drops have broad clinical application prospects in the treatment of ocular diseases. However, there is still a lack of qualitative and quantitative research on the related substances in them. This study first established an analytical method for related substances in baicalin eye drops, providing a scientific basis for product development and quality control. Through LC-Q/TOF-MS/MS, seven related substances were preliminarily identified in baicalin eye drops, namely scutellarin, oroxylin A-7-O-glucuronide, oroxin A, quercetin-7-O-glucuronide/quercetin 3-O-glucuronide, chrysin-7-O-glucuronide, baicalein, and scutellarein. The quantitative analysis of oroxin A, scutellarin and oroxylin A-7-O-glucuronide was carried out by HPLC. The chromatographic column was the NanoChrom AR C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase was 0.1% phosphoric acid aqueous solution (A)-acetonitrile (B), with gradient elution. The column temperature was 20 ℃, the flow rate was 0.8 mL·min-1, and the detection wavelength was 254 nm. The established method has strong specificity, high sensitivity, and good precision. In this study, a method for the qualitative and quantitative analysis of related substances in baicalin eye drops was established, providing a basis for ensuring their quality.

baicalin eye drop  /  related substance  /  structural identification  /  HPLC  /  LC-MS/MS
赵红芳, 陈悦, 吴涛, 潘可欣, 卢骏, 李清. 黄芩苷滴眼液中有关物质的定性与定量分析. 药学学报, 2025 , 60 (11) : 3483 -3490 . DOI: 10.16438/j.0513-4870.2025-0437
Hong-fang ZHAO, Yue CHEN, Tao WU, Ke-xin PAN, Jun LU, Qing LI. Qualitative and quantitative assessment of related substances in baicalin eye drops[J]. Acta Pharmaceutica Sinica, 2025 , 60 (11) : 3483 -3490 . DOI: 10.16438/j.0513-4870.2025-0437
Year 2025 volume 60 Issue 11
213
104
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Article Info
doi: 10.16438/j.0513-4870.2025-0437
  • Receive Date:2025-04-17
  • Online Date:2026-09-20
  • Published:2025-11-12
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  • Received:2025-04-17
  • Revised:2025-08-20
Affiliations
    1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
    2Beijing Novelpharm Pharmaceutical Biotechnology Co., Ltd., Beijing 101102, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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