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Objective <p>An efficient, robust, sustainable, and eco-friendly RP-HPLC method has been developed for the simultaneous estimation of Nirmatrelvir and Ritonavir in bulk and fixed-dose combined drug formulations.</p> Methods <p>The RP-HPLC method was systematically developed by incorporating the Analytical Quality by Design concept, including risk assessment and response, and the Box-Behnken design statistical approach to define the critical method parameters and generate a reliable design space. Also, the RP-HPLC method was performed using an isocratic mobile phase of acetonitrile and 0.1% orthophosphoric acid (80:20, v/v) at a flow rate of 1mL/min on a C18 column (250 × 4.6&#xa0;mm, 5&#xa0;μm) under UV detection at 210&#xa0;nm, separated with shorter retention times of approximately 3.4 and 4.4&#xa0;min for Nirmatrelvir and Ritonavir, respectively.</p> Results and Conclusion <p>The RP-HPLC method was fully validated for various parameters, including those outlined in ICH Q2 (R1), and demonstrated higher linearity, precision, accuracy, and sensitivity. The RP-HPLC method was found to be stability-indicating based on the forced degradation studies conducted. The greenness, practicality, analytical performance, and sustainability of the developed method were assessed by green metric tools, blue applicability grade index, red analytical performance index, white analytical chemistry, and multicolor assessment, which yielded higher scores, qualifying it for industrial implementation.</p> Graphical Abstract <p></p>

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Development and Validation of Stability-Indicating RP-HPLC Method for Nirmatrelvir and Ritonavir: Integration of Quality by Design and Multi-Metric Analytical Evaluation

  • 期刊论文

  • 发表日期：

    2026年4月27日

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  • Ramreddy Godela,
  • Lakshmi Satya Sri Kovvuri,
  • Ganesh Chunchulu,
  • Tharun Kumar Manumole,
  • Durga Prasad Beda

摘要

Objective

An efficient, robust, sustainable, and eco-friendly RP-HPLC method has been developed for the simultaneous estimation of Nirmatrelvir and Ritonavir in bulk and fixed-dose combined drug formulations.

Methods

The RP-HPLC method was systematically developed by incorporating the Analytical Quality by Design concept, including risk assessment and response, and the Box-Behnken design statistical approach to define the critical method parameters and generate a reliable design space. Also, the RP-HPLC method was performed using an isocratic mobile phase of acetonitrile and 0.1% orthophosphoric acid (80:20, v/v) at a flow rate of 1mL/min on a C18 column (250 × 4.6 mm, 5 μm) under UV detection at 210 nm, separated with shorter retention times of approximately 3.4 and 4.4 min for Nirmatrelvir and Ritonavir, respectively.

Results and Conclusion

The RP-HPLC method was fully validated for various parameters, including those outlined in ICH Q2 (R1), and demonstrated higher linearity, precision, accuracy, and sensitivity. The RP-HPLC method was found to be stability-indicating based on the forced degradation studies conducted. The greenness, practicality, analytical performance, and sustainability of the developed method were assessed by green metric tools, blue applicability grade index, red analytical performance index, white analytical chemistry, and multicolor assessment, which yielded higher scores, qualifying it for industrial implementation.

Graphical Abstract