Determination of 16 Metallic Elements in Water for Injection by ICP-MS / 中国药师

ABSTRACT

Objective:To establish the methods for the determination of Mg,Al,K,Ca,Cr,Cu,Zn,As,Se,Ag,Cd,Sn,Ba,Pb,Na and Hg in water for injection. Methods:The sixteen metallic elements in water for injection were determined by ICP-MS. The collision cell technology ( CCT) was used to minimize the multiple atomic interference, and the matrix effect and signal drift were compensated by using Li, Sc, Ge, In, Ir and Bi as the internal standards and the samples were directly acidified to detect the metallic elements. Results:The detection limit range of the 16 metallic elements were from 0. 009 to 0. 165 ng·ml-1. The calibration curves showed good linearity (r≥0. 999 0). The recoveries were within the range of 80%-120%(n=6). Conclusion:The method is simple, rapid and accurate. It can be used to determine the contents of metallic elements to reduce the potential exceeding limit risk of toxic metal el-ements in water for injection. The methods also can provide reference for the more strict quality evaluation of water for injection.