Simultaneous determination of 10 impurities in ibuprofen and its preparations by UPLC method

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Author: YUN Xiaofei  ZHANG Yanxia QIAN Yujuan HAN Feng XIAO Honghua YAN Zeman WANG Meng

Affiliation: Beijing Chaoyang Food and Drug Safety Monitoring Center, Beijing 100124, China

Keywords: Ibuprofen Ultra-performance liquid chromatography Impurities Toxicity Quality control

DOI: 10.12173/j.issn.2097-4922.202512006

Reference: YUN Xiaofei, ZHANG Yanxia, QIAN Yujuan, HAN Feng, XIAO Honghua, YAN Zeman, WANG Meng.Simultaneous determination of 10 impurities in ibuprofen and its preparations by UPLC method[J]. Yaoxue QianYan Zazhi, 2026, 30(5): 804 - 812. DOI: 10.12173/j.issn.2097-4922.202512006[Article in Chinese]  Copied

Abstract
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Abstract

Objective To establish an ultra-performance liquid chromatography (UPLC) method for the simultaneous determination of 10 impurities in ibuprofen and its preparations.

Methods An ACQUITY UPLC BEH C₁₈ chromatographic column (100 mm×2.1 mm, 1.7 μm) was used, and gradient elution was performed with 0.05% phosphoric acid solution and acetonitrile as mobile phases at a flow rate of 0.3 mL/min. The column temperature was 30 ℃, and the detection wavelength was 214 nm.

Results Baseline separation (separation degree > 1.5) was achieved between the main component of ibuprofen and each impurity peak. The linear relationship of each impurity was good within the range of 1-50 μg/mL (r > 0.999 0). The average recovery rate ranged from 97.96% to 106.01%, the precision RSD was less than 5%, the limit of detection was from 0.013 to 0.112 μg/mL, and the limit of quantification was from 0.043 to 0.375 μg/mL. The impurity content in 20 batches of samples was less than 1.5‰.

Conclusion The method is simple, accurate, and sensitive, and can be used for quality control of 10 impurities in ibuprofen and its preparations.

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