Abstract

A CASE STUDY FOR RISK ASSESSMENT STUDY OF ELEMENTAL IMPURITIES IN PHARMACEUTICAL DRUGS BY INDUCTIVELY COUPLED PLASMA MASS SPECTROMETER (ICP-MS)

Dr. Amit Gosar, Amit Joglekar* and Kundan D. Patil

Abstract

Elemental impurities in drug products /substances from several sources are often observed; they may be residues or impurities from catalyst required during synthesis or from material of construction (e.g., through interactions with processing equipments or container/closure systems or by being present in components of the drug substance (Figure No.1). From January 1, 2018 a new guideline ICH Q3D, regarding elemental impurities in drug products became effective published by International Conference on Harmonization. In this article, a case study is represented by developing a selective and highly sensitive Inductive Coupled Plasma Mass Spectrometry (ICP-MS) method for the determination of Elemental impurity in Domperidone (DMP) drug substance. Determination of Cadmium, Lead, Arsenic, Mercury, Cobalt, Vanadium, Nickel, Molybdenum and Chromium content in Domperidone by Inductively Coupled Plasma Mass Spectrometer (ICP- MS) is carried out in the present work. A method is developed and study was performed to support the method precision, accuracy and Linearity. Specifically, three representative batches of drug substance Domperidone (DMP) were analyzed and the results were interpreted. The method was found suitable for the intended purpose. The linearity for all the standards was established from 30% to 150% of the concentration range (correlation coefficients were found more the 0.99). Similarly the accuracy for all the standards at 30% concentration level was estimated and recoveries were obtained in the range of 93 to 112 (%w/w). The precision of the same preparation was also found within the acceptable limit.

Keywords: Risk Assessment, Elemental Impurities, Domperidone and Inductively Coupled Plasma Mass spectrometer (ICP-MS).