ICP-MS Determination of Seven Element Impurities in Pregabalin Oral Solution
To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the determination of seven elemental impurities(Cd,Pb,Hg,As,Co,V and Ni)in pregabalin oral solution.115 In,209 Bi,69 Ge and 45 Sc were used as internal standards.The content of each element impurities was calculated by standard curve.The results show that the specificity of seven elemental impurities was good.The detection limits of the elemental impurities were from 0.007 to 0.3 μg·L-1 and the quantitation limits were from 0.02 to 1.0 μg·L-1.The correlation coefficients(r)were all above 0.999.The recoveries were between 93.5%to 103.8%and RSD was between 2.4%to 4.5%.The repeatability RSD was between 3.2%to 6.2%.The robustness RSD was between 1.2%to 8.8%.Test results of seven elements in three batches of samples met the requirements of ICH Q3D.This method is simple,rapid,sensitive,and accurate for the determination of seven elemental impurities in pregabalin oral solution.
pregabalin oral solutioninductively coupled plasma mass spectrometry(ICP-MS)element impuritiesinternal standards
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