Method Development and Validation of Elementa...

Method Development and Validation of Elemental Impurities (Heavy metals) in Sugammadex Injection By ICP/MS

Author Name : Kunwar Sanjeev Singh, Dr. Rahul Kumar

ABSTRACT AnInductively Coupled Plasma Mass Spectrometry (ICP-MS) method was developed for determination of elemental impurities in Sugammadex injection as per ICH Q3D.On January 1, 2018, new guidelines regarding elemental impurities (heavy metals) in brand and generic drug products went into effect. Considering the safety of the formulated dosage form provided to the patient, a new ICH guideline will assure appropriate controls for particular metals that are likely to be present exclusively in pharmaceutical products and ingredients. General Chapter <233> of United State Pharmacopoeia (USP) recommends the use of modern instrumental techniques (Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) or ICP-Mass Spectrometry (ICP-MS), in place of the colorimetric test used in USP<231>.Modern methods provide better analytical tests to detect elemental impurities (heavy metals), which is helpful to protect patient by controlling these impurities at safe levels in drug products. Method was developed on ICP/MS instrument to control the elemental impurities (heavy metals) as per ICH guidelines.The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, and Range. All the parameters were found within the acceptable limits as per ICH Q3D.ICP/MS method was specific, accurate, precise and suitable for the analysis of elemental impurities in Sugammadex Injection.