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<p>Ensartinib is a potent anticancer agent utilized in treating non-small cell lung cancer; however, accurately quantifying it within biological and pharmaceutical samples poses a significant analytical challenge. To overcome this, our study introduces and validates two highly sensitive and selective spectrofluorometric techniques for its estimation. The primary approach relies on producing a high fluorescent derivative through a interaction of ensartinib with fluorescamine in a pH 7.5 borate buffer, with measurements taken at λex/em = 392/483 nm. Second approach is formed by quenching of Erythrosine B fluorescence after it forms an ion-pair complex with the analyte in Britton–Robinson buffer (pH 4). The recorded Fluorescence detected at an excitation/emission wavelength pair of 527/550 nm. The fluorescamine and Erythrosine B methods showed hight linearity over concentration ranges of 20–1000 ng mL⁻¹ and 50–1000 ng mL⁻¹, respectively. The methods also showed good sensitivity, of LODs of 5.44 and 15.70 ng /mL and LOQs of 16.47 and 46.36 ng /mL, respectively. All validation experiments were performed in accordance with ICH guidelines.The environmental performance of both techniques was assessed using the (scores of 86 and 90) of Analytical Eco-Scale and the AGREE metric (0.77 and 0.81), confirming their strong green analytical profile. The techniques were applied successfully to the analysis of market formulations (Capsules) and spiked human plasma samples, confirming robustness and suitability of quality control. In addition, their performance indicates that they may be useful for future pharmacokinetic investigations and bioequivalence studies.</p>

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The Utility of Green Chemistry in Spectrofluorometric Determination of Ensartinib; An Oncological Drug Using Fluorescamine and Erythrosine B in Pharmaceutical Preparation and Biological Fluid

  • 期刊论文

  • 发表日期：

    2026年7月30日

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  • Hesham Salem,
  • Nadeen Emad,
  • Mohamed Rabea,
  • Ahmed M. Ahmed,
  • Afraim Safwat,
  • Shahd M. Mohamed,
  • Dalal Abdallah,
  • Sama Al Naser,
  • Mahmoud Abdelgaleel

摘要

Ensartinib is a potent anticancer agent utilized in treating non-small cell lung cancer; however, accurately quantifying it within biological and pharmaceutical samples poses a significant analytical challenge. To overcome this, our study introduces and validates two highly sensitive and selective spectrofluorometric techniques for its estimation. The primary approach relies on producing a high fluorescent derivative through a interaction of ensartinib with fluorescamine in a pH 7.5 borate buffer, with measurements taken at λex/em = 392/483 nm. Second approach is formed by quenching of Erythrosine B fluorescence after it forms an ion-pair complex with the analyte in Britton–Robinson buffer (pH 4). The recorded Fluorescence detected at an excitation/emission wavelength pair of 527/550 nm. The fluorescamine and Erythrosine B methods showed hight linearity over concentration ranges of 20–1000 ng mL⁻¹ and 50–1000 ng mL⁻¹, respectively. The methods also showed good sensitivity, of LODs of 5.44 and 15.70 ng /mL and LOQs of 16.47 and 46.36 ng /mL, respectively. All validation experiments were performed in accordance with ICH guidelines.The environmental performance of both techniques was assessed using the (scores of 86 and 90) of Analytical Eco-Scale and the AGREE metric (0.77 and 0.81), confirming their strong green analytical profile. The techniques were applied successfully to the analysis of market formulations (Capsules) and spiked human plasma samples, confirming robustness and suitability of quality control. In addition, their performance indicates that they may be useful for future pharmacokinetic investigations and bioequivalence studies.