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Home Articles Vol 27,2024 No.3 Detail

Determination of related substances in gluaric anhydride by HPLC

Published on Apr. 12, 2024Total Views: 1749 times Total Downloads: 599 times Download Mobile

Author: LIU Min 1, 2 LIAN Zhenxia 1, 2 LIU Yanxin 1, 2 WANG Fan 1, 2 LI Xia 1, 2 YANG Haixia 1, 2

Affiliation: 1. Shandong Academy of Pharmaceutical Sciences, Ji’nan 250101, China 2. Key Laboratory for Chemical Drug Research of Shandong Provincial, Ji’nan 250101, China

Keywords: Glutaric anhydride Succinic acid Adipic acid Related substances High performance liquid chromatography

DOI: 10.12173/j.issn.1008-049X.202401122

Reference: LIU Min, LIAN Zhenxia, LIU Yanxin, WANG Fan, LI Xia, YANG Haixia.Determination of related substances in gluaric anhydride by HPLC[J].Zhongguo Yaoshi Zazhi,2024, 27(3):382-387.DOI: 10.12173/j.issn.1008-049X.202401122.[Article in Chinese]

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Abstract

Objective  To establish a method for the determination of related substances in glutaric anhydride by HPLC.

Methods  The HPLC method was performed on a Waters Symmetry C18 column (250 mm×4.6 mm, 5 µm) with mobile phase of methanol-0.1% phosphoric acid solution (3 ∶ 97) at a flow rate of 0.9 mL/min, the column temperature was 30 ℃, the injection volume was 20 μL, and the detection wavelength was set at 210 nm.

Results  Succinic acid, adipic acid and unknown impurities in glutaric anhydride can be effectively detected. The linear range was 5.925-59.251 μg/mL for succinic acid (r=0.999 6), 6.210-62.100  μg/mL for adipic acid (r=0.999 7), and 5.110-8 516.000 μg/ mL for glutaric acid (r=0.999 9). The average recoveries of succinic acid and adipic acid were 100.92% (RSD=0.86%) and 105.89% (RSD=2.99%) (n=9), respectively.

Conclusion  The method has strong specificity, high sensitivity and good accuracy, and can be used for the related substances determination of glutaric anhydride.

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References

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