Determination of 10 Elemental Impurities in Lansoprazole API by ICP-MS
A method based on inductively coupled plasma mass spectrometry(ICP-MS)was developed for the simultaneous determination of 10 impurity elements(Pb,As,Cd,Hg,V,Ni,Co,Li,Cu and Sb)in the raw material of Lansoprazole API(for injection).After microwave digestion,the samples were analyzed by collision cell-ICP-MS with 45Sc,103Rh,and 193Ir as the internal standards.The correlation coefficients of the standard curves for 10 target elements were larger 0.9990.The detection limit was 0.0077-0.6136μg/L with the quantitative limit of 0.0257-2.0455 μg/L.The content of these elements in three batches of Lansoprazole API(for injection)was far below their corresponding limited value,and the recovery of these elements in spiked samples was 75.1％-123％.The method is simple,rapid,accurate,and can be used for the determination of elemental impurities in Lansoprazole API(for injection).
LansoprazoleElemental impuritiesInductively coupled plasma mass spectrometry(ICP-MS)Methodology validation
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