Abstract:
OBJECTIVE To compare the determination methods for aluminum residual in Compound Amino Acid injection by graphite furnace atomic absorption spectrometry(GFAAS) and inductively coupled plasma-mass spectrometry(ICP-MS).
METHODS The content of aluminum in 59 batches of Compound Amino Acid injection produced by 12 pharmaceutical companies was determined by GFAAS with polarized Zeeman background correction and ICP-MS.
RESULTS There was a good linear relationship of GFAAS in the concentration range of 5-40 ng·mL
-1(
r=0.995 3), and the average recovery was 100.1%, RSD=4.80%(
n=9). There was a good linear relationship of ICP-MS in the concentration range of 5-100 ng·mL
-1 (
r=0.999 9), and the average recovery was 104.7%, RSD=1.75%(
n=9).
CONCLUSION The measured values of the two methods are basically the same. There is a significant difference in residues of aluminum between the products from different manufacturers and it is necessary to control residual aluminum in Compound Amino Acid injection.