Analytical method development and validation for the evaluation of related substances in Apalutamide by RP-HPLC

  • Dipak Chandrakant Kulkarni Department of Chemistry, GITAM School of Science, Visakhapatnam, India
  • Anima Sunil Dadhich Department of Chemistry, GITAM School of Science, Visakhapatnam, India
  • Mukthinuthalapati Mathrusri Annapurna GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

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 guidelines

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Author Biographies

Dipak Chandrakant Kulkarni, Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Anima Sunil Dadhich, Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Mukthinuthalapati Mathrusri Annapurna, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

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Kulkarni DC, Dadhich AS, Annapurna MM. Analytical method development and validation for the evaluation of related substances in Apalutamide by RP-HPLC. JDDT [Internet]. 15Jun.2024 [cited 17Jul.2024];14(6):150-6. Available from: https://jddtonline.info/index.php/jddt/article/view/6641