Determination of antioxidants in plastic infusion packaging materials and containers and the migration to injections / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a microwave extraction-HPLC method for determination of antioxidant 1010, antioxidant 330, antioxidant 1076, and antioxidant 168 in plastic infusion packaging materials and containers, and investigate the migration of the antioxidants from the materials to the injection. METHODS: Taking the contents of antioxidants as indices, the best extraction condition was determined with or thogonal experiments and statistical analysis. The separation of antioxidants was performed on a Sunfire-C18 (4.6 mm×150 mm, 5 μm) chromatographic column at 40℃, and the detection wavelength was set at 280 nm. The mobile phase consisted of acetonitrile, tetrahydrofuran, and water (6∶3∶1) at a flow rate of 1.5 mL·min-1, and the injection volume was 20 μL. RESULTS: The optimized extraction process was extracting 2 g of sample at 100℃ for 30 min. The calibration curves of antioxidant 1010, antioxidant 330, antioxidant 1076, and antioxidant 168 were linear over the concentration range from 0.004 to 0.5 mg·mL-1 (r=0.999 9) and the average recoveries of the antioxidants ranged from 96.8% to 103.7% (RSD<2%, n=9). CONCLUSION: This method is convenient, sensitive, and reliable and it can be used for the determination of antioxidants in plastic infusion materials and their migration to the injection.