Analytical method development and validation for the evaluation of related substances in Apalutamide by RP-HPLC
Abstract
Apalutamide is an anti-cancer agent used for the management of prostate cancer. A new stability indicating RP-HPLC method (Gradient mode) has been developed for the estimation of Apalutamide and its related substances using Waters Alliance system (Model no. 2996 and 2695) with Inertsil ODS-3 (250 × 4.6 mm, 5μm) column (PDA detector) was used for the present study. A mixture of Ammonium phosphate buffer solution and Acetonitrile (30: 70, v/v) was used as the mobile phase for the chromatographic study (Flow rate: 1.0 mL/min; Detection wavelength: 243 nm). Stress degradation studies were performed and the method was validated as per ICH guidelines.
Keywords: Apalutamide, RP-HPLC, Related substances, Impurities, Stability indicating, Validation, ICH guidelines.
Keywords:
Apalutamide, RP-HPLC, Related substances, Impurities, Stability indicating, Validation, ICH guidelinesDOI
https://doi.org/10.22270/jddt.v14i6.6641References
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