Determination of 7 elements in pharmaceutical excipient triacetin by ICH requirement
Objective To establish the inductively coupled plasma mass spectrometry(ICP-MS)to determine V,Co,Ni,As,Cd,Pb and Hg in pharmaceutical excipient triacetin.Methods The elements in triacetin were determined by ICP-MS after the microwave digestion treatment.The measurement results were corrected through online adding the internal standard solution.Results The standard curves showed good linearity(r was 0.998~0.999).The recovery was 80.7%~105.8%(n=6).Conclusion The method has good accuracy and reproducibility,and can be used for the determination of element impurities in pharmaceutical excipient triacetin.