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<p>In this study, a novel, cost-effective, accurate, and ecofriendly stability-indicating RP-HPLC technique was developed and validated for the simultaneous measurement of sofosbuvir (SOF) and velpatasvir (VEL) in tablet dosage form. The Box-Behnken design was used for multivariate optimization of the experimental parameters of RP-HPLC. The molarity of heptane sulfonic acid sodium salt (HSA), volume of ethanol, and volume of acetonitrile were used to develop mathematical models and study the effects of these factors on various responses. Heptane sulfonic acid sodium (1 mM) – acetonitrile : ethanol (80 : 11 : 9 v/v) as the mobile phase, made up the optimal and expected condition. The SOF and VEL retention times were found to be 5.505 and 3.472 minutes, respectively, and the linearity was shown across the concentration range of 20 – 100 μg/mL and 5 – 25 μg/mL, respectively, with a correlation coefficient (R<sup>2</sup>) &gt; 0.999. Studies on forced degradation under acid, basic, oxidative, photolytic, and thermal conditions revealed the drug’s well-resolved peak and the degradation products’ peaks as well. For the simultaneous determination of sofosbuvir and velpatasvir in conventional laboratory analysis, this newly suggested approach is one that is quick, reliable, and cost effective. Furthermore, greenness was analyzed utilizing four cutting-edge metrics, including GAPI, AES, AMGS, and AGREE.</p>

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A Box-Behnken Design Optimization-Based Ecofriendly Stability-Indicating RP-HPLC Method for Determination of Sofosbuvir and Velpatasvir

  • 期刊论文

  • 发表日期：

    2025年8月1日

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  • Lalitha Repudi,
  • Hemant Kumar Tatapudi,
  • Mohana Vamsi Nuli,
  • Narendra Tammineni,
  • Gorantla Nagamallika

摘要

In this study, a novel, cost-effective, accurate, and ecofriendly stability-indicating RP-HPLC technique was developed and validated for the simultaneous measurement of sofosbuvir (SOF) and velpatasvir (VEL) in tablet dosage form. The Box-Behnken design was used for multivariate optimization of the experimental parameters of RP-HPLC. The molarity of heptane sulfonic acid sodium salt (HSA), volume of ethanol, and volume of acetonitrile were used to develop mathematical models and study the effects of these factors on various responses. Heptane sulfonic acid sodium (1 mM) – acetonitrile : ethanol (80 : 11 : 9 v/v) as the mobile phase, made up the optimal and expected condition. The SOF and VEL retention times were found to be 5.505 and 3.472 minutes, respectively, and the linearity was shown across the concentration range of 20 – 100 μg/mL and 5 – 25 μg/mL, respectively, with a correlation coefficient (R2) > 0.999. Studies on forced degradation under acid, basic, oxidative, photolytic, and thermal conditions revealed the drug’s well-resolved peak and the degradation products’ peaks as well. For the simultaneous determination of sofosbuvir and velpatasvir in conventional laboratory analysis, this newly suggested approach is one that is quick, reliable, and cost effective. Furthermore, greenness was analyzed utilizing four cutting-edge metrics, including GAPI, AES, AMGS, and AGREE.