Abstract
A sensitive, simple, rapid and robust reverse phase HPLC method was developed for the determination of Potential genotoxic impurity Hydrazine hydrate in Ibrutinib by using Salicyldehyde as derivatization Reagent and Octadecyl as stationary phase with column dimension of 4.6 mm × 250 mm and 5 µm particle size (Inertsil ODS-3V). 0.02 M Ammonium dihydrogen orthophosphate in water and acetonitrile in the ratio (35:65) was used as mobile phase. Isocratic elution mode was used for the separation, using a flow rate of 1.0 mL/min and column oven temperature of 40 °C. Detection was carried out at wavelength of 354 nm. Developed method is validated as per ICH guidelines and found to be linear, accurate, specific, selective, precise and robust. Test solution was found to be stable up to 48 hrs. This method can be successfully applied for the determination of Hydrazine hydrate in Ibrutinib for routine analysis and stability assessment.
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