Objective: To develop a precise, accurate, sensitive and selective analytical method using inductively coupled plasma – optical emission spectroscopy (ICP-OES) for the determination of platinum and palladium in Donepezil hydrochloride raw material, a reversible acetyl cholinesterase inhibitor.Methods: The method developed and validated uses dry ashing for the extraction of platinum and palladium from Donepezil hydrochloride. Ash thus obtained was leached into an acidic solution followed by analysis of platinum and palladium using ICP-OES at wavelength 306.471 nm and 340.458 nm respectively. The method was studied for the various validation parameters including precision, accuracy, linearity, etc. for both the elements.Results: The method was found to be linear in the wide working range of 0.2 µg/ml to16 µg/ml with a correlation coefficient of 0.9998 for platinum and 0.1µg/ml to 8µg/ml with a correlation coefficient of 0.9999 for palladium. The recoveries of platinum and palladium from the spiked samples of Donepezil hydrochloride at three different spiking levels were found to be in the range of 86.87 – 98.59% for both platinum and palladium. The limit of detection was found as 0.1 µg/ml and 0.05 µg/ml for platinum and palladium respectively while the limit of quantitation was found to be 0.2 µg/ml and 0.1 µg/ml for platinum and palladium.Conclusion: The results of the validation studies indicate that the proposed method can be used for the simultaneous determination of platinum and palladium in Donepezil hydrochloride to ensure the quality and purity of Donepezil hydrochloride as a raw material for formulating the pharmaceutical formulations.Â
