DETERMINATION OF ELEMENTAL IMPURITIES IN ESLICARBAZEPINE ACETATE A PARTIAL SEIZURE DRUG BY USING ICP-MS

Eslicarbazepine acetate is a chemical compound that has found medical use as a partial seizure drug. Monitoring of heavy metals (As, Mn, Cd, Cr, V, Mo, Cu, and Sb) in-process, intermediates, and final drug substances is an important activity in the pharmaceutical industry because of the potential for toxicity and the risk of serious health hazards even at very low doses. This research article established and validated an easy and rapid analytical method for determining eight heavy metals in Eslicarbazepine acetate. Drugs must first be processed through acid digestion using microwave radiation before being analyzed for these elemental impurities. The % RSD of the LOQ solution was found to be < 20.0 for all the elements. The analytical method seems linear, with a correlation coefficient > 0.99. Eslicarbazepine acetate sample amounts spiked at three different concentrations, resulting in acceptable percentage recoveries of heavy metal ions ranging from 70% to 150%. Individually, precision and robustness for all conditions met the acceptable limits. Heavy metal analysis by ICP-MS is a powerful technique; therefore, the present method is selective, sensitive, accurate, linear, precise, and robust. It can also be used for routine quantitatively determining eight elemental impurities in Eslicarbazepine acetate.