Development and Validation of Analytical Method for Quantitative Estimation of Multiple Metal Impurities in Dobutamine Hydrochloride using ICPMS Spectroscopy

Objectives: Primary objective of the present study is to develop and validate an accurate and linear analytical method for precise estimation of Vanadium, Cobalt, Nickel, Arsenic, Cadmium, Mercury, Thallium and Lead elemental impurities present in the Dobutamine Hydrochloride active pharmaceutical ingredient using inductively coupled plasma mass spectrometry. Materials and Methods: Argon gas is used as carrier gas and helium gas as collision gas, 5% nitric acid is used as diluent, plasma gas flow rate is 15 l/m, spray chamber temperature is 2°C, helium gas flow rate is 5 ml/m, integration time is 0.3 s and tune mode is He gas. Microwave digester is used to extract the elemental impurities. The developed method was validated according to the Q3D guidelines provided by the International Conference on Harmonization. Results: The correlation coefficients for all the eight metals were found to be 1, and their concentration variation (%) in standard check solution was estimated to be less than 20. The system precession was found to be less than 20% of relative standard deviation and the linearity calibration curve was linear over the concentration range of 0.25J to 2.50J specification level. The obtained recoveries are well within the acceptance criteria of 70%-150%. Conclusion: The low relative standard deviation and high recoveries of the method confirm the suitability of the method for precise estimation of the above metal impurities in Dobutamine Hydrochloride active pharmaceutical ingredient.