Determination of 12 inorganic elements in phloroglucinol injection by ICP-MS
10.19778/j.chp.2025.05.013
- VernacularTitle:ICP-MS法测定间苯三酚注射液中12种无机元素的含量
- Author:
Ying SUN
1
;
Kai HE
;
Huan CHEN
;
Ling MA
;
Caiyu ZHANG
Author Information
1. 宁夏回族自治区药品检验研究院,宁夏回族自治区药品质量控制与评价重点实验室,银川 750002
- Publication Type:Journal Article
- Keywords:
phloroglucinol injection;
ICP-MS;
microwave digestion;
elemental impurities;
quality evaluation
- From:
Drug Standards of China
2025;26(5):533-537
- CountryChina
- Language:Chinese
-
Abstract:
Objective:A method was first established for determination simultaneously of 12 elements including B,Al,Si,As,Cd,Hg,Pb,Co,Ni,V,Cu and Sb in phloroglucinol injection,and investigate the elemental impuri-ty content of commercially available phloroglucinol injection.Methods:Samples were digested with microwave-as-sisted acid and determined by inductively coupled plasma chromatography(ICP-MS).Results:This method has a good linear relationship.The average recovery rate was range from 88.9％-100.4％.The repeatability RSD were range from 0.6％-5.8％,and the precision RSD were between 0.4％-8.1％.The methodological validation meets the requirements.B,Al,Si,As,Cd,Co,Ni,V,Cu were detected to varying degrees in 9 batches of sam-ples,and there were significant differences in content among different enterprises.The sources of elemental impuri-ties were deeply explored in combination with the production process,medicinal property and pharmaceutical packa-ging material.Conclusion:The new established method has strong specificity,high accuracy,reliable results,and can be used as a quality evaluation method for elemental impurities in phloroglucinol injection.
