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.
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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