阿司匹林丁香酚酯颗粒剂有关物质检测方法的建立与验证

doi:10.11843/j.issn.0366-6964.2023.08.034

Abstract

Abstract: This study aims at establishing a method for the determination of related substances in aspirin eugenol ester(AEE) granules. Ultra performance liquid chromatography(UPLC) was used to detect the related substances of AEE granules, with the column was Phenomenex luna C18 (150 mm×4.6 mm, 5 μm), mobile phase was 0.5% phosphoric acid squeous solution and acetonitrile, flow rate was 1.0 mL·min^-1, wavelength was 279 nm, column temperature was 35℃, injection volume was 10 μL. Under the selected chromatographic conditions, the separation of the main peak of AEE and the impurity peak was well. Impurity A had a good linear relationship with the peak area in the concentration range of 0.25-60.0 μg·mL^-1, R²=0.999 2 (n=8). The material recoveries ranged from 98.34% to 100.15% (n=9, RSD=0.68%), and the robustness of the method under different conditions was well, the RSD value was less than 3.33%. The method is simple and specific, which suitable for the determination of related substances in AEE granules after methodological verification.

Key words: aspirin eugenol ester, UPLC, related substances, method validation

CLC Number:

S859.79

WANG Zhixia, BAI Lixia, QIN Zhe, LIU Xiwang, YANG Yajun, LI Shihong, GE Wenbo, LI Jianyong. Establishment and Validation of the Determination Method for the Related Substances in Aspirin Eugenol Ester Granules[J]. Acta Veterinaria et Zootechnica Sinica, 2023, 54(8): 3500-3509.

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Establishment and Validation of the Determination Method for the Related Substances in Aspirin Eugenol Ester Granules

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