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Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations Kona, Subramanya Srinivas Changali, Mallesh Kalva, Mahesh Lakka, Narasimha Swamy Gadolinium Method validation Method development Microwave assisted digestion system Gadolinium-based contrast agents (GBCAs) Inductively coupled plasma mass-spectrometry Gadolinium-based contrast agent interacts with the human body temporarily and improves the pictures of inside of the body produced by magnetic resonance imaging, computed tomography, X-rays and ultrasound and it also helps to distinguish the normal from abnormal conditions. In this study, the authors developed a simple, rapid, reliable and robust inductively coupled plasma mass-spectrometry method for estimation of gadolinium in gadolinium-based contrast agents to check the drug quality and ensure the patient safety. The samples were digested at 160°C using the microwave digestion system and the gadolinium was extracted in 0.4% (w/w) nitric acid. Interference of deposited gadolinium on sample cone and skimmer cone were investigated and evaluated. The developed method was validated as per ICH Q2 (R1) guideline and USP<730>. The precision was evaluated with six independent assays of gadolinium in each gadolinium-based contrast agent. The test method was found linear (r2 > 0.999) with five different levels covered from 25~200%, and accurate, mean recoveries were 92.5~107.5% at three different levels covered from 50~150%. The robustness was performed by changing the nitric acid concentration (0.4±0.04%, w/w) in diluent system. This method is suitable to quantitatively determine the amount of gadolinium in gadolinium-based contrast agent of drug products in presence of excipients used in formulation and also in drug substance. Atlanta Publishing House LLC 2020-06-30 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf https://www.eurjchem.com/index.php/eurjchem/article/view/1972 10.5155/eurjchem.11.2.133-138.1972 European Journal of Chemistry; Vol. 11 No. 2 (2020): June 2020; 133-138 2153-2257 2153-2249 eng https://www.eurjchem.com/index.php/eurjchem/article/view/1972/pdf_1972 Copyright (c) 2020 Authors