Development and  Validation of Inductively Coupled Plasma Mass Spectrometry Method for Simultaneous Determination of TIN(SN) content in Excipients and Formulations

JagadeswaraRao K^1,2, Murali Mohan SV ²and *Rama Rao Malla^1
1Department of Biochemistry, Cancer Biology Lab, GIS, GITAM University, Visakhapatnam, India
²Analytical Research and development Department, Shilpa Medicwere Limited, India
³Department of Chemistry, GIS, GITAM University, Visakhapatnam, India

A B S T R A C T
The pharmaceutical formulation manufacturing process use some of polymers, which contains traces of inorganic elements like Tin (Sn) content. The traces of inorganic elements were determined by using inductively coupled plasma mass spectroscopy (ICP-MS). It is a sensitive method used to determine the inorganic elements by atomic mass value. In the present study Tin (Sn) was extracted by the sample using microwave-assisted digestion with hydrochloric acid. Different validation parameters were employed to evaluate the method in terms of selectivity, specificity, method precision, accuracy, intermediate precision and standard measurement un certainty. The mass value of tin element is 118 as per the perkin Elmer instrument recommendations. The results indicate that this method could be used for the routine measurement of tin (Sn) in the pharmaceutical laboratories.
Keywords: inductively coupled plasma mass spectrometry, Analytical Method development, Analytical Method validation and Tin (Sn) content