Measurement method of ATBC migration in disposable infusion set
Objective To establish GC method for measuring the migration of acetyl tributyl citrate (ATBC) as disposable infusion set being used and to study and validate the safety of the clinical use.Methods Respectively,we simulated clinical infusion environment with non-fat-soluble and fat-soluble solutions to investigate the accuracy and validity of the measurement for the migration of ATBC by GC method.In non-fat soluble solution,Column:Shimadzu Rtx-624 capillary column (30 m × 0.53 mm,3 μm);In fat-soluble solution,Column:DB-624 capillary column (30 m × 0.45 mm,3 μm);The following conditions were the same,hydrogen:40 mL/min;air:400 mL/min;nitrogen:15 mL/min as the mobile phase;within standard:hexadecane;column temperature:240℃;injection volume:1 μL.Results In non-fat-soluble solution,ATBC at 10 to 200 μg/mL showed a good linear relationship within a correlation coefficient of 0.9999,the average recovery was 97.44％ (RSD 2.4％);In fat-soluble solution,ATBC at 10 to 200 μg/mL showed a good linear relationship within a correlation coefficient of 0.9999,the average recovery was 92.02％ (RSD 7.9％).Conclusions Measured migration of ATBC by gas GC method has a high accuracy and a good recovery rate.The method can be used for the content analysis of ATBC,which provides a reference for the quality control of infusion device containing ATBC and further research.
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