Determination and health risk assessment of 12 metal impurity elements in valsartan capsules by induc-tively coupled plasma mass spectrometry
OBJECTIVE To establish an inductively coupled plasma mass spectrometer(ICP-MS)method for the determi-nation of 12 metal impurities(Mg,Al,V,Cr,Mn,Co,Ni,Cu,As,Cd,Tl &.Pb)in the contents and capsule shell of valsar-tan capsules and conduct health risk assessments of 4 hazardous elements.METHODS The contents and shell of valsartan cap-sules were digested by microwave respectively.The contents of 12 metal impurity elements were determined by ICP-MS standard curve with Sc,Ge,In and Bi as internal standards.Moreover,hazard quotient(HQi)and hazard index(HI)were utilized for evaluating the health risk of Cr,Ni,Cu and Pb.RESULTS The correlation coefficients of calibration curves of 12 metal impurity elements were all＞0.999.The spiked recoveries of the contents ranged from 81.2％to 113.4％,And the spiked recoveries of capsule shells were between 83.2％and 117.4％with RSD＜15％.The results of health risk assessment showed that hazard index(HI)of Cr,Ni,Cu and Pb elements in contents and shells were＜1.CONCLUSION The established ICP-MS method is simple,rapid and accurate for determining 12 metal impurity elements in the contents and shells of valsartan capsules.And the exposure values of Cr,Ni,Cu and Pb in 16 batches of valsartan capsules have no significant health risk.
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