Quality Assessment of Single-use Infusion Pump Products
Objective To simulate extraction and evaluate the safety of 4 phthalate ester(PAE)plasticizers that might be added to single-use infusion pump products,and carry out migration tests of the PAEs in several commonly used clinical drugs.Methods HPLC was performed on an ACE Excel 5 C18(4.6 mm×250 mm,5 μm)column,using acetonitrile(added 0.1％glacial acetic acid)as mobile phase A,water(added 0.1％glacial acetic acid)as mobile phase B for gradient elution.The flow rate was 1.0 ml/min,the column temperature was 30 ℃,the detection wavelength was 238 nm,and the injection volume was 50 μl.Results The linear ranges of DMP,DBP,DEHP and DOP were 0.008-8.00,0.08-8.00,0.008-8.00,0.08-8.00 μg/ml(r=1.0000,1.0000,0.9999,1.0000),respectively.The limits of detection(LOD)were 0.2,2,0.2,1.6 ng,respectively;the limits of quantification(LOQ)were 0.4,4,0.4,4 ng,respectively;the RSDs of precision and stability tests were all less than 2.0％.The recoveries were 99.25％-100.45％,with RSDs less than 2.0％(n=6).The extraction test results showed that DEHP was detected in the solution extracted by 50％ethanol,and no PAEs were extracted by buffer solutions of pH 3.0 and pH 10.0.The migration test results showed that only DEHP was detected in solution leached by Flurbiprofen Axetil Injection,and the migration amount was lower than the tolerable intake(TI).Conclusion The method is simple,specific and sensitive,and is suitable for the determination of the addition of 4 PAEs in single-use infusion pump products and quality evaluation.
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