Determination of seven elemental impurities in amlodipine besylate tablets by ICP-MS
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.
amlodipine besylate tabletselemental impurityinternal standardsmicrowave digestioninductively coupled plasma mass spectrometry(ICP-MS)quality control
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