DETERMINATION OF ELEMENTAL IMPURITIES IN CLOMIPRAMINE HYDROCHLORIDE CAPSULES USP 25MG, 50MG AND 75MG BY INDUCTIVE COUPLED PLASMA MASS SPECTROMETRY (ICP-MS).

Determination of elemental impurities “Cadmium, Lead, Arsenic, Mercury, Cobalt, Vanadium and Nickel” in Clomipramine Hydrochloride capsules USP by Inductive coupled plasma mass spectrometer (ICP-MS). The Microwave digester system, Nitric acid and Hydrogen peroxide were used for sample preparation. specified limit of elemental impurities in Clomipramine Hydrochloride Capsule USP (25mg, 50mg, 75mg,) are taken from ICHQ3D.

The validation parameters and acceptance criteria were carried out in accordance with USP general chapter <232), <233> and ICHQ3D. During validation specific, precise, linear, accurate, rugged and LOD-LOQ parameters were performed. Range of the validated method is LOQ to 200% of specification level for each elemental Impurities. The limit of detection and limit of quantification are 8.33% and 25% of specification level for each elemental impurity. The validated method was effectively useful to determine the elemental impurities in Clomipramine Hydrochloride capsules USP

Keywords: Inductive coupled plasma mass spectrometer (ICP-MS), Clomipramine Hydrochloride Capsule USP, Elemental impurities, ICH guideline.