Migration determination and risk assessment of 20 elements in ambroxol hydrochloride injection in glass ampoule packaging
Objective To determine the migration amount of 20 elements in ambroxol hydrochloride injection from glass ampoule packaging and to determine and evaluate the risk of migration amount in sample.Methods Inductively coupled plasma mass spectrometry(ICP-MS)was used to determine the migration amounts of 17 elements,including B,Al,Li,Ba,Mg,Fe,Zn,Mn,Cd,Ti,Co,Cd,Pb,As,Sb,Ce and Zr.Inductively coupled plasma emission spectrometry(ICP-OES)was used to determine the migration amounts of Si,K and Ca.Results The recovery of 20 elements was 90.6％～107.7％.The detection limit of 17 elements by ICP-MS was 0.004～2.8 ng·mL-1,and the detection limit of Si,K and Ca by ICP-OES were 7.4,10.1,7.9 ng·mL,respectively.According to the maximum daily intake,all the elements were within the safe range.Si,B,Al,Fe,Ti,Ba and Li were mainly removed from the glass ampoule.Conclusion ICP-MS and ICP-OES analysis is effective for the determination of 20 elements in ambroxol hydrochloride injection migrating from glass ampoule.Migration amount and migration trend can provide parameters for risk monitoring and prediction of glass delamination.
万方数据
维普
