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<p>A stability-indicating high-performance liquid chromatographic (HPLC) method for Vibegron (VBG) was developed and validated based on the analytical quality-by-design (AQbD) concept. Screening of critical factors were studied using risk assessment, followed by Plackett–Burman design, and optimization of critical factors were done using an I-optimal response surface design. The optimized chromatographic conditions include a Kromasil Classic C18 column (250 × 4.6&#xa0;mm, 5&#xa0;µm) and a mobile phase consisting of acetonitrile (A) and 10&#xa0;mM ammonium acetate buffer pH adjusted to 4.5 with trifluoroacetic acid (B); in a ratio of (A:B; 46:54 v/v) ratio, at a flow rate of 0.8&#xa0;mL/min, with a detection wavelength of 248&#xa0;nm. The method has been validated as per ICH guidelines and demonstrated linearity (<i>R</i><sup>2</sup> &gt; 0.997), precision (% RSD &lt; 2), and accuracy (99.97 ± 1.61% recovery). VBG was found to be sensitive during stress testing under various environmental conditions, including hydrolytic, oxidative, thermal, and photolytic stress. A total of 18 degradation products were separated, identified, and quantified using the developed method. The method's sustainability was assessed using the Whiteness assessment via the RGB 12 algorithm, the Analytical GREEness Tool (AGREE), the Complex Green Analytical Procedure Index, and the Blue Applicability Index, ultimately confirming that it is both green and practical. The developed method can be applied in pre-formulation studies, quality control, and pharmacovigilance.</p>

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Sustainable Stability Analysis of Vibegron: A Novel Chromatographic Method Development and Validation

  • 期刊论文

  • 发表日期：

    2025年8月18日

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  • Nidhi Vadnere,
  • Mital Patel

摘要

A stability-indicating high-performance liquid chromatographic (HPLC) method for Vibegron (VBG) was developed and validated based on the analytical quality-by-design (AQbD) concept. Screening of critical factors were studied using risk assessment, followed by Plackett–Burman design, and optimization of critical factors were done using an I-optimal response surface design. The optimized chromatographic conditions include a Kromasil Classic C18 column (250 × 4.6 mm, 5 µm) and a mobile phase consisting of acetonitrile (A) and 10 mM ammonium acetate buffer pH adjusted to 4.5 with trifluoroacetic acid (B); in a ratio of (A:B; 46:54 v/v) ratio, at a flow rate of 0.8 mL/min, with a detection wavelength of 248 nm. The method has been validated as per ICH guidelines and demonstrated linearity (R2 > 0.997), precision (% RSD < 2), and accuracy (99.97 ± 1.61% recovery). VBG was found to be sensitive during stress testing under various environmental conditions, including hydrolytic, oxidative, thermal, and photolytic stress. A total of 18 degradation products were separated, identified, and quantified using the developed method. The method's sustainability was assessed using the Whiteness assessment via the RGB 12 algorithm, the Analytical GREEness Tool (AGREE), the Complex Green Analytical Procedure Index, and the Blue Applicability Index, ultimately confirming that it is both green and practical. The developed method can be applied in pre-formulation studies, quality control, and pharmacovigilance.