Determination of Content and Migration of Five Antioxidants in Quantitative Valve of Nitroglycerin Aerosol by HPLC
Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of five antioxidants in quantitative valves of nitroglycerin aerosol,and to investigate the migration of antioxidants in nitroglycerin aerosols.Methods The chromatographic column was Inertsil®ODS-SP column(150 mm×4.6 mm,5 µm),the mobile phase was water-tetrahydrofuran-acetonitrile(10∶30∶60,V/V/V),the flow rate was 1.5 mL/min,the column temperature was 30℃,the detection wavelength was 280 nm,and the injection volume was 20 µL.Results The linear ranges of antioxidants 168,330,1010,1076,BHT were 0.2-250 µg/mL(r≥0.999 8,n=6),the limits of detection(LOD)were 1.58,0.27,0.38,0.94,0.24 µg/mL,the limits of quantification(LOQ)were 3.84,0.91,1.44,3.02,0.60 µg/mL.The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n=6).The recovery rates of the above five antioxidants were 100.67%,99.97%,99.93%,99.60%,and 99.63%,with RSDs of 0.47%,0.21%,0.93%,0.44%,and 0.60%(n=9),respectively.The detection levels of antioxidants 168,330,1010,1076 in the component materials such as the internal gasket,valve stem,valve chamber,and pipette of the quantitative valve of nitroglycerin aerosol were lower than those of corresponding analytical evaluation threshold(AET),and no antioxidant BHT was detected.After 0,3,and 6 months of accelerated tests,the migration volumes of antioxidants 168,330,1010,1076,and BHT in the component materials of the quantitative valve were all lower than those of corresponding AET.Conclusion This method is simple,highly sensitive,and accurate,with good repeatability and stability,which can be used for the determination of the content and migration of five antioxidants in quantitative valves of nitroglycerin aerosol.