Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2024
  • Volume: 17
  • Issue: 12

Stability indicating RP-UPLC method for the simultaneous estimation of niraparib and abiraterone in pharmaceutical dosage forms

1Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Visakhapatnam, India

2School of Pharmacy, Anurag University, Ghatkesar, Hyderabad

*Corresponding Author E-mail: sdarga@gitam.in

Online published on 9 May, 2025.

Abstract

Niraparib and Abiraterone are anti-cancer agents. A new stability indicating UPLC method has been developed and validated for the simultaneous assay of Niraparib and Abiraterone using Acquity UPLC HSS T3 Column with UV detection at 215 nm within a run time of 3 minutes where Niraparib was eluted at 1.169 min and that of Abiraterone at 0.684 min. Linearity was observed over the concentration range of 2.5-15 μg/mL for Niraparib and 12.5-75 μg/mL for Abiraterone respectively and the regression equations were found to be y=68577x+10960 and y=66848x+7064.7 for Niraparib and Abiraterone respectively. The LOD was found to be 0.32 μg/ml and 0.46 μg/ml whereas the LOQ was found to be 0.98 μg/ml and 1.38 μg/ml for Niraparib and Abiraterone respectively.

Keywords

Niraparib, Abiraterone, UPLC, Validation, Forced degradation studies, ICH guidelines