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<p>A novel, simple and highly sensitive spectrofluorimetric approach has been developed and validated for the first time for determination of berotralstat through derivatization reaction using fluorescamine as a fluorescent probe. The reaction was carried out in buffered medium at pH 7.5, using a borate buffer. After being illuminated at 390&#xa0;nm, the fluorescence intensity of the resulting product was measured at 480&#xa0;nm. The proposed approach demonstrated linearity within the concentration range of 100 to 1000 ng mL<sup>− 1</sup>. LOD and LOQ are 6.98 and 26.36 ng mL<sup>− 1</sup>, respectively. Pharmaceutical capsules of berotralstat were successfully evaluated in addition to spiked biological fluid. The statistical data has been validated in accordance with ICH criteria. Additionally, it was applied to examine the content uniformity in accordance with US Pharmacopeia requirements. Furthermore, the results of the ecology scale scores indicated that the analytical process involved was green.</p>

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Utility of fluorescamine for spectrofluorimetric quantitation of berotralstat hydrochloride in spiked human plasma and content uniformity test and evaluation of method greenness

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月12日

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  • Hesham Salem,
  • Mohamed Gamal Eldeen,
  • Basmala Sayed,
  • Menna Kamel,
  • Mostafa Embarak,
  • Salma Mokhtar,
  • Hoda Madian,
  • Basmala Bahaa,
  • Sama Alnaser,
  • Mahmoud Abdelgaleel

摘要

A novel, simple and highly sensitive spectrofluorimetric approach has been developed and validated for the first time for determination of berotralstat through derivatization reaction using fluorescamine as a fluorescent probe. The reaction was carried out in buffered medium at pH 7.5, using a borate buffer. After being illuminated at 390 nm, the fluorescence intensity of the resulting product was measured at 480 nm. The proposed approach demonstrated linearity within the concentration range of 100 to 1000 ng mL− 1. LOD and LOQ are 6.98 and 26.36 ng mL− 1, respectively. Pharmaceutical capsules of berotralstat were successfully evaluated in addition to spiked biological fluid. The statistical data has been validated in accordance with ICH criteria. Additionally, it was applied to examine the content uniformity in accordance with US Pharmacopeia requirements. Furthermore, the results of the ecology scale scores indicated that the analytical process involved was green.