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Purpose <p>Tadalafil, a phosphodiesterase-5 inhibitor, is widely used for the treatment of erectile dysfunction and pulmonary hypertension. Its accurate and reproducible quantification is essential for quality control and regulatory compliance. Existing analytical methods often lack environmental sustainability or systematic optimization. This research focused on creating and validating a reliable, sensitive, and environmentally friendly RP-HPLC method for determining Tadalafil in pharmaceutical dosage forms, utilizing a Quality by Design (QbD) strategy.</p> Method <p>The reversed-phase HPLC method was developed with methanol and 0.1% OPA as the mobile phase, substituting the commonly used acetonitrile to enhance environmental safety. Method optimization was performed using a Box-Behnken Design under the QbD framework. Validation was carried out according to ICH Q2(R1) guidelines. Key performance metrics were benchmarked against ten recently published HPLC methods for Tadalafil quantification.</p> Result <p>The newly developed method achieved a retention time of 6.5&#xa0;min and demonstrated a linearity range from 5 to 25&#xa0;µg/mL. The limits for detection and quantification were found to be 0.52&#xa0;µg/mL and 1.58&#xa0;µg/mL, respectively. With a precision of 0.35% RSD and a recovery rate of 99.5% to 101.2%, the method also attained an AGREE greenness score of 0.71, outperforming current methods. Benchmarking confirmed better environmental and analytical performance.</p> Conclusion <p>The validated RP-HPLC method offers a reliable, reproducible, and sustainable solution for Tadalafil estimation. The integration of QbD principles ensures robustness and adaptability, while the green chemistry approach reduces ecological impact. This technique is ideally suited for ongoing quality control processes in both research and industrial pharmaceutical contexts.</p> Graphical Abstract <p></p>

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QbD Driven Box-Behnken Design Assisted Optimization, Stability-Indicating Validation, and Method Performance Benchmarking with Greenness Assessment of Tadalafil by RP-HPLC Method

  • 期刊论文

  • 发表日期：

    2026年4月21日

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  • Kiran N. Gaikwad,
  • M. S. Palled

摘要

Purpose

Tadalafil, a phosphodiesterase-5 inhibitor, is widely used for the treatment of erectile dysfunction and pulmonary hypertension. Its accurate and reproducible quantification is essential for quality control and regulatory compliance. Existing analytical methods often lack environmental sustainability or systematic optimization. This research focused on creating and validating a reliable, sensitive, and environmentally friendly RP-HPLC method for determining Tadalafil in pharmaceutical dosage forms, utilizing a Quality by Design (QbD) strategy.

Method

The reversed-phase HPLC method was developed with methanol and 0.1% OPA as the mobile phase, substituting the commonly used acetonitrile to enhance environmental safety. Method optimization was performed using a Box-Behnken Design under the QbD framework. Validation was carried out according to ICH Q2(R1) guidelines. Key performance metrics were benchmarked against ten recently published HPLC methods for Tadalafil quantification.

Result

The newly developed method achieved a retention time of 6.5 min and demonstrated a linearity range from 5 to 25 µg/mL. The limits for detection and quantification were found to be 0.52 µg/mL and 1.58 µg/mL, respectively. With a precision of 0.35% RSD and a recovery rate of 99.5% to 101.2%, the method also attained an AGREE greenness score of 0.71, outperforming current methods. Benchmarking confirmed better environmental and analytical performance.

Conclusion

The validated RP-HPLC method offers a reliable, reproducible, and sustainable solution for Tadalafil estimation. The integration of QbD principles ensures robustness and adaptability, while the green chemistry approach reduces ecological impact. This technique is ideally suited for ongoing quality control processes in both research and industrial pharmaceutical contexts.

Graphical Abstract