Safety Monitoring

Determination of bisphenol A in disposable infusion set by UPLC-MS

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  • Shanghai Food and Drug Packaging Materials Control Center, Shanghai 201203, China

Received date: 2023-03-13

  Online published: 2024-06-21

Abstract

Objective: To establish an UPLC-MS method for the determination of bisphenol A in disposable infusion set. Methods: ZORBAX Eclipse Plus C18 column (50 mm×3.0 mm,1.8 μm) was used for separation. Methanol and 0.3% ammonia were selected as mobile phases for gradient elution. Multiple reaction monitoring (MRM) mode was used for detection. Results: The limits of detection and quantitation of bisphenol A were 3.1 ng·mL-1 and 10.2 ng·mL-1, respectively. And the linear relationship was good in the range of 10-200 ng·mL-1 (r=0.999 7). The recoveries of the added standard in pH 3.5 buffer solution, pH 8.0 buffer solution, 15% ethanol solution and 0.9% sodium chloride injection were 90.8%-102.3%. The method was applied to the detection of 4 batches of disposable infusion sets, and bisphenol A was detected in 1 batch. Conclusion: The method is simple, accurate, stable, sensitive, and has a wide linear range. It can be used for the determination of bisphenol A in disposable infusion set.

Cite this article

DING Hao . Determination of bisphenol A in disposable infusion set by UPLC-MS[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(12) : 2121 -2126 . DOI: 10.16155/j.0254-1793.2023.12.18

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