Multielemental Screening and Analytical Method Validation for Determination of Elemental Impurity in Sucroferric Oxyhydroxide by Using (ICP-MS)

Abstract

A highly selective, specific, precise sensitive and reliable ICPMS method has been developed and validated by using ICP-MS for the determination of multielement in Sucroferric oxyhydroxide. The described ICP-MS method provides specific detection and quantification of minor and trace elements from 0.3J(30%) to 2J(200%) of its individual specification of each element i.e Ag, As, Au, Ba, Cd, Co, Cr, Cu, Hg, Ir, Li, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, Tl,  and V.The analytical method found to be Linear for each individual element with working concentration range from 30%, 50%, 100%, 150% and 200% i.e 0.3J, 0.5J, 1J, 1.5J and 2J with correlation coefficient not less than 0.990.The % recoveries of elemental impurities of each individual elements at three different concentrations with spiking in samples were found to be an acceptable range as 70% to 150%.The method was found to be precise and robust and its relative standard deviation was below 20%.The actual observed relative standard deviation in Precision was found to be in an acceptable range. Therefore developed method can be use for routine quantitative analysis of elemental impurities like Ag, As, Au, Ba, Cd, Co, Cr, Cu, Hg, Ir, Li, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, Tl, and V to ensure the quality of drug product.