CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 2: 117 - 117-123

DOI: https://doi.org/10.2095-3593.2026.040006

Determination of Related Substances in the Raw Material of Bevantolol Hydrochloride by HPLC and Methodological Validation

  • 天晴 谭
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  • 1.China Pharmaceutical University school of life science and technology， Jiangsu Nanjing 210000， China；
    2.Shijiazhuang NO.4 Pharmaceutical Co.， Ltd.， Hebei Shijiazhuang 050000， China；
    3.College of Pharmaceutical Sciences， Shenyang Pharmaceutical University， Liaoning Shenyang 110016， China

Received date: 2025-09-19

  Revised date: 2026-01-09

  Accepted date: 2026-05-19

  Online published: 2026-05-19

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Abstract

Objective： To establish and validate a high-performance liquid chromatography (HPLC) method for the determination of related substances in bevantolol hydrochloride bulk drug substance. Methods： A CAPCELL PAK MGⅡ C18 column (4.6 mm×250 mm，5 μm) was used with mobile phase A consisting of phosphate buffer (pH 6.0)-methanol (20∶80) and mobile phase B of phosphate buffer-methanol (90∶10) in a gradient elution mode. The flow rate was 1.0 mL·min-1， the detection wavelength was set at 280 nm， and the column temperature was maintained at 30 ℃. Results： Baseline separation was achieved between bevantolol hydrochloride and eight known impurities (A-H). The resolution between each impurity and the main peak， as well as between the impurities themselves， was greater than 1.5. All impurities showed good linearity within their respective concentration ranges (R2>0.999). The average recovery ranged from 95.9% to 102.7% with an RSD values are all less than or equal to 5.97% (n=9). The test solution remained stable at room temperature for 8 h. The method demonstrated good precision： the content ranges for impurity C， other individual impurities， and total impurities in 12 samples were 0.007%， 0.005% and 0.016%， respectively. Conclusion： The established method is specific， sensitive， accurate， and precise. It is suitable for the determination of related substances in bevantolol hydrochloride raw material and provides a reliable analytical basis for its quality control.

Key words： ; font-size:medium; ">Bevantolol hydrochloride； Related substance detection； High performance liquid chromatography (HPLC)； Impurity analysis； Quality control

Cite this article

天晴 谭 . Determination of Related Substances in the Raw Material of Bevantolol Hydrochloride by HPLC and Methodological Validation[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(2) : 117 -117-123 . DOI: 10.2095-3593.2026.040006

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