Determination of heavy metals and harmful elements in Xiyanping Injection by ICP-MS
10.7501/j.issn.0253-2670.2019.24.013
- Author:
Jia LIANG
1
Author Information
1. Jiangxi Qingfeng Pharmaceutical Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Ag;
Al;
As;
Ba;
Bi;
Cd;
Co;
Cr;
Cu;
Fe;
Harmful elements;
Heavy metals;
Hg;
Inductively coupled plasma mass spectrometry;
Li;
Ni;
Pb;
Sb;
Sn;
V;
Xiyanping Injection
- From:
Chinese Traditional and Herbal Drugs
2019;50(24):6002-6008
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish a method for the determination of 17 heavy metals and harmful elements in Xiyanping Injection (XI). Methods: The samples were digested and determined by inductively coupled plasma mass spectrometry (ICP-MS). The RF power was 1 550 W; The peristaltic pump speed was 0.3 r/s; The plasma gas velocity was 15 L/min; The auxiliary gas velocity was 0.2 L/min; The carrier gas velocity was 1 L/min; The sampling depth was 10 mm and the signal was measured for three times. Results: The detection limits of Li, Al, V, Cr, Fe, Co, Ni, Cu, As, Ag, Cd, Sn, Sb, Ba, Hg, Pb, Bi were 9.584, 49.858, 0.504, 3.016, 51.209, 0.142, 1.116, 0.675, 0.924, 1.421, 0.403, 2.770, 0.711, 3.584, 0.590, 0.411, 0.169 ng/mL, and the quantitative limits were 28.933, 151.085, 1.528, 9.139, 155.179, 0.429, 3.381, 2.046, 2.799, 4.312, 1.220, 8.394, 2.155, 10.861, 1.965, 1.244, and 0.513 ng/mL within a certain concentration range, respectively. The response value had a good linear relationship with the concentration (r > 0.999 1); The RSDs (n = 12) of the injection precision test were in the range of 0.8%-3.8%, the RSDs (n = 6) of the repeatability were in the range of 0.7%-2.0%, and the average recoveries of 17 elements were in the range of 95.7%-104.8%. Detection results of 20 batches of mass production samples: Ag was not detected, Li and V were detected but lower than the quantitative limit, the maximum mass concentration of Al, Ni, Cu, As, Ba, Hg and Pb were 0.685, 0.013, 0.007, 0.006, 0.208, 0.070 and 0.027 μg/ml respectively, Cr, Fe, Co, Cd, Sn, Sb, and Bi were not detected or lower than the quantitative limit. Conclusion: The specificity, linearity, sensitivity, precision, accuracy and durability of the method were all good. It can be used to determine 17 elements of Li, Al, V, Cr, Fe, Co, Ni, Cu, As, Ag, Cd, Sn, Sb, Ba, Hg, Pb and Bi in XI. The test results of 17 elements in 20 batches of mass production samples were less than the limit requirements, meeting the requirements.
