Abstract Niraparib and Abiraterone in a combined dosage form offer a fortunate regimen for treating cancers, mainly those resistant to conventional therapies cast in cancer treatment. The present study intends to develop a novel RP-HPLC method for simultaneously estimating Niraparib and Abiraterone in combined dosage forms. The approach was optimized using a Zodiac C18 column and a mobile phase of acetonitrile and 0.01N Na2HPO4 buffer (pH 2.5) at a 60:40 V/V ratio with a 1 mL/min flow rate. The detection was done at 260 nm, accomplishing retention times of 2.2 and 2.7 min for Niraparib and Abiraterone by isocratic elution mode. The developed method validation was conducted according to ICH Q2R1 provisions to confirm the assessing system suitability, precision, accuracy, linearity, robustness, specificity, and sensitivity. The linearity range for Niraparib and Abiraterone was assessed to be 1.25–7.5 μg/mL and 5–75 μg/mL respectively. The LOD and LOQ of NRP and ABT were computed to be 0.07 µg/mL, 0.21 µg/mL, and 0.20 µg/mL, 0.62 µg/mL, respectively, by standard deviation method. The forced degradation studies confirmed the stability-indicating capability of the method, showing the degradation susceptibility of Niraparib and Abiraterone under various stress conditions. The method is robust, economical, and suitable for routine analysis due to its high sensitivity, shorter run time, and effective separation of analytes and degradants. Article highlights <UnorderedList Mark="Bullet"> <ItemContent> A Novel RP-HPLC method for estimation of Niraparib and Abiraterone in synthetic mixture and tablet dosage form. </ItemContent> <ItemContent> Design of a simple and economical solvent system for the separation of Niraparib and Abiraterone. </ItemContent> <ItemContent> Optimization of shorter elution time with isocratic elution and effective resolution. </ItemContent> <ItemContent> Development of a stability-indicating method through comprehensive forced degradation studies. </ItemContent> <ItemContent> Development of a specific, sensitive, and robust method. </ItemContent> </UnorderedList> Graphical abstract

A novel RP-HPLC stability-indicating method for simultaneous estimation of Niraparib and Abiraterone in synthetic mixtures and combined tablet formulations

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2025年5月15日

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Krishnaphanisri Ponnekanti,
Ramreddy Godela,
Divya Reddy Solipeta,
K. Sujatha,
Durga Prasad Beda

摘要

Abstract

Niraparib and Abiraterone in a combined dosage form offer a fortunate regimen for treating cancers, mainly those resistant to conventional therapies cast in cancer treatment. The present study intends to develop a novel RP-HPLC method for simultaneously estimating Niraparib and Abiraterone in combined dosage forms. The approach was optimized using a Zodiac C18 column and a mobile phase of acetonitrile and 0.01N Na₂HPO₄ buffer (pH 2.5) at a 60:40 V/V ratio with a 1 mL/min flow rate. The detection was done at 260 nm, accomplishing retention times of 2.2 and 2.7 min for Niraparib and Abiraterone by isocratic elution mode. The developed method validation was conducted according to ICH Q2R1 provisions to confirm the assessing system suitability, precision, accuracy, linearity, robustness, specificity, and sensitivity. The linearity range for Niraparib and Abiraterone was assessed to be 1.25–7.5 μg/mL and 5–75 μg/mL respectively. The LOD and LOQ of NRP and ABT were computed to be 0.07 µg/mL, 0.21 µg/mL, and 0.20 µg/mL, 0.62 µg/mL, respectively, by standard deviation method. The forced degradation studies confirmed the stability-indicating capability of the method, showing the degradation susceptibility of Niraparib and Abiraterone under various stress conditions. The method is robust, economical, and suitable for routine analysis due to its high sensitivity, shorter run time, and effective separation of analytes and degradants.

Article highlights

A Novel RP-HPLC method for estimation of Niraparib and Abiraterone in synthetic mixture and tablet dosage form.

Design of a simple and economical solvent system for the separation of Niraparib and Abiraterone.

Optimization of shorter elution time with isocratic elution and effective resolution.

Development of a stability-indicating method through comprehensive forced degradation studies.

Development of a specific, sensitive, and robust method.

Graphical abstract