Determination of seven elemental impurities in amlodipine besylate tablets by ICP-MS
10.19778/j.chp.2024.03.007
- VernacularTitle:ICP-MS法测定苯磺酸氨氯地平片中7种元素杂质
- Author:
Naijun ZHU
1
;
Weibin JIN
;
Huafeng ZHANG
Author Information
1. 苏州市药品检验检测研究中心,江苏苏州 215104
- Keywords:
amlodipine besylate tablets;
elemental impurity;
internal standards;
microwave digestion;
inductively coupled plasma mass spectrometry(ICP-MS);
quality control
- From:
Drug Standards of China
2024;25(3):257-264
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for simultaneous determination of 7 elemental impurities(V,Co,Ni,As,Cd,Hg Pb)in amlodipine besylate tablets based on inductively coupled plasma mass spectrometry(ICP-MS).Methods:After the samples were treated by microwave digestion,the solution was analyzed by ICP-MS.Ge,In,Bi were selected as the internal standards.The established method was validated.The contents of 7 elemental impurities in amlodipine besylate tablets from 54 enterprises were determined by this method.Results:The content of(V,Co,Ni,As,Cd,Hg,Pb had good linear relationship in the ranges of 1-100,1-100,1-100,1-100,1-100,0.5-4,1-100 ng·mL-1,respectively.The correlation coefficients(r)all above 0.999 4.The detec-tion limits and quantification limits were in the range of 0.000 4-0.018 4 ng·mL-1 and 0.001 4-0.061 2 ng·mL-1.The RSD of precision was less then 1.8％.The RSD of repeatability was less then 6.1％.The average re-coveries(n=9)were between 85.4％-106.5％,while their RSD was less then 4.7％.The content of 7 elemental impurities in 54 sample batches were in accordance with the limit value.Conclusion:The method is simple,rapid,accurate,reliable and highly sensitive,and can be used for the quality control of elemental impurities in amlodipine besylate tablets.
