Metabolism Analysis

Determination of PBT oligomers migration in budesonide aerosol by UPLC

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  • Shanghai Institute for Food and Drug Control, NMPA Key Lab for Quality Analysis of Chemical Drug Preparations,Shanghai 201203, China

Received date: 2021-11-09

  Online published: 2024-06-24

Abstract

Objective: To establish a method for the determination of polybutylene terephthalate(PBT) oligomers migration in budesonide aerosol by ultra high performance liquid chromatography (UPLC). Methods: The analysis was performed on an ACQUITY BEH C18 column(100 mm×2.1 mm, 1.8 μm)at 35 ℃. The mobile phase of water(A)and acetonitrile(B)was subjected to gradient elution(0-1.5 min, 40%A→25%A; 1.5-8 min, 25%A; 8-9 min, 25%A→10%A; 9-12 min,10%A; 12-13 min, 10%A→40%A;13-16 min, 40%A)at a flow rate of 0.4 mL·min-1. And the detection wavelength was 240 nm. Results: PBT dimer and PBT trimer showed a good linear relationship in the range of 0.1-10.5 μg·mL-1(r=1.000), and PBT tetramer and PBT pentamer showed a good linear relationship in the range of 0.02-2.0 μg·mL-1(r=1.000); the average recoveries of the four compounds were 94.2%-104.7%; the detection limits of the four compounds were all less than 0.02 μg·mL-1.In the solutions of budesonide aerosol,the migration of PBT dimer and PBT trimer were detected in different degrees, but PBT tetramer or PBT pentamer was not found. Conclusion: The method is accurate, reliable, selective,simpleand rapid. It can be used for the determination of PBT oligomers migration and the quality evaluation of aerosol packing materials.

Cite this article

ZHANG Ye, SONG Dong-mei, JIANG Wen-ming, LE Jian . Determination of PBT oligomers migration in budesonide aerosol by UPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(5) : 809 -813 . DOI: 10.16155/j.0254-1793.2022.05.09

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