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<p>The simultaneous quantification of elexacaftor, tezacaftor, and ivacaftor in their laboratory-prepared ternary mixture, dosage form, and spiked human plasma has been made possible by the development and validation of a straightforward, accurate, environmentally friendly, and selective thin-layer chromatography (TLC) approach. Using ethyl acetate‒<i>n</i>-hexane‒methanol‒glacial acetic acid (40:40:20:2, <i>V/V</i>) as the mobile phase and ultraviolet detection at 250&#xa0;nm, the combination was detached on silica gel TLC plates G60 F<sub>254</sub>. For each medication, all the criteria were tuned within a linearity range of 10‒200&#xa0;ng/band. The low limit of detection values for elexacaftor, tezacaftor, and lvacaftor were found to be 2.85, 2.97, and 2.8&#xa0;ng/band, respectively, with good sensitivity. The devised method was applied to spiked human plasma and tablets. Good recovery findings confirmed the high efficacy of the suggested strategy. The suggested method’s level of greenness was assessed using the eco-scale, analytical greenness (AGREE) metric tools, and green analytical procedure index.</p>

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Green thin-layer chromatography‒densitometric method for the determination of elexacaftor, tezacaftor, and ivacaftor simultaneously in pharmaceutical preparation and spiked human plasma

  • 期刊论文

  • 发表日期：

    2025年5月19日

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  • Hesham Salem,
  • Dina Z. Mazen,
  • Belal M. Abdelghany,
  • Abdelrahman Medhat,
  • Anas Mahmoud,
  • Ragaa Laban,
  • Shahd Hissham,
  • Saad Rabiea,
  • Amany Abdelaziz

摘要

The simultaneous quantification of elexacaftor, tezacaftor, and ivacaftor in their laboratory-prepared ternary mixture, dosage form, and spiked human plasma has been made possible by the development and validation of a straightforward, accurate, environmentally friendly, and selective thin-layer chromatography (TLC) approach. Using ethyl acetate‒n-hexane‒methanol‒glacial acetic acid (40:40:20:2, V/V) as the mobile phase and ultraviolet detection at 250 nm, the combination was detached on silica gel TLC plates G60 F254. For each medication, all the criteria were tuned within a linearity range of 10‒200 ng/band. The low limit of detection values for elexacaftor, tezacaftor, and lvacaftor were found to be 2.85, 2.97, and 2.8 ng/band, respectively, with good sensitivity. The devised method was applied to spiked human plasma and tablets. Good recovery findings confirmed the high efficacy of the suggested strategy. The suggested method’s level of greenness was assessed using the eco-scale, analytical greenness (AGREE) metric tools, and green analytical procedure index.