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<p>The goal is to create an RP-HPLC technique that is easy to utilize, quick, and specific enough to measure Abiraterone and Niraparib in bulk and prescription dose forms using Box–Behnken response surface design with application to dissolution studies. Optimization was performed by Box–Behnken design with selecting mobile phase ratio of volume of acetonitrile, volume of trifluoroacetic acid, and flow rate as factors and evaluating responses, namely, retention time and tailing factor through Symmetry C18 column (150 × 4.6&#xa0;mm, 3.5&#xa0;µm) with a mobile phase of acetonitrile: 0.1% TFA (40:60 v/v) at a flow rate of 1&#xa0;mL/min, detection at 257&#xa0;nm, and a runtime of 6&#xa0;min. Box–Behnken design compared the effect of flow rate, ratio of acetonitrile, and volume of TFA on retention time and tailing factor, and optimized conditions for increased sensitivity. Retention times were 2.013&#xa0;min for Abiraterone and 3.655&#xa0;min for Niraparib. The technique was found to be excellent in linearity with correlation coefficients (<i>R</i><sup>2</sup>) of 0.999 for both drugs. Validation parameters such as system suitability, accuracy, precision, linearity, specificity, robustness, LOD, and LOQ were in compliance with ICH guidelines. Forced degradation and dissolution studies established the stability-indicating nature of the method and applicability for release profiling. This technique is an important improvement in the field of pharmaceutical analysis, providing a robust platform for antineoplastic drug development research and quality control.</p> Graphical abstract <p></p>

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Stability-indicating RP-HPLC method using Box–Behnken design for simultaneous estimation of Abiraterone and Niraparib in bulk and combined dosage form with application to dissolution studies

  • 期刊论文

  • 发表日期：

    2025年8月21日

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  • Anusha Gandi,
  • Krishna Manjari Pawar Amgoth

摘要

The goal is to create an RP-HPLC technique that is easy to utilize, quick, and specific enough to measure Abiraterone and Niraparib in bulk and prescription dose forms using Box–Behnken response surface design with application to dissolution studies. Optimization was performed by Box–Behnken design with selecting mobile phase ratio of volume of acetonitrile, volume of trifluoroacetic acid, and flow rate as factors and evaluating responses, namely, retention time and tailing factor through Symmetry C18 column (150 × 4.6 mm, 3.5 µm) with a mobile phase of acetonitrile: 0.1% TFA (40:60 v/v) at a flow rate of 1 mL/min, detection at 257 nm, and a runtime of 6 min. Box–Behnken design compared the effect of flow rate, ratio of acetonitrile, and volume of TFA on retention time and tailing factor, and optimized conditions for increased sensitivity. Retention times were 2.013 min for Abiraterone and 3.655 min for Niraparib. The technique was found to be excellent in linearity with correlation coefficients (R2) of 0.999 for both drugs. Validation parameters such as system suitability, accuracy, precision, linearity, specificity, robustness, LOD, and LOQ were in compliance with ICH guidelines. Forced degradation and dissolution studies established the stability-indicating nature of the method and applicability for release profiling. This technique is an important improvement in the field of pharmaceutical analysis, providing a robust platform for antineoplastic drug development research and quality control.

Graphical abstract