Development of eco-friendly sensitive HPLC method for determination of Letrozole and assessment of validation

IF 4.1 Q1 CHEMISTRY, ANALYTICAL

Talanta Open Pub Date : 2025-02-25 DOI:10.1016/j.talo.2025.100425

Hayam Mahmoud Lotfy , Asena Ayse Genc , M. Soner Bay , Gizem Tiris , Reem H. Obaydo , Nevin Erk

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Abstract

The greening of analytical methods has gained interest in the field of quantitative analysis to reduce environmental impact and improve analyst's safety and health. For postmenopausal women with hormone-responsive advanced breast cancer, Letrozole (LTZ) has been a standard first-line endocrine therapy A green HPLC method was developed, optimized, validated, and applied for quantification of the LTZ in tablets. Experiments were conducted on the Inertsil ODS- 3® C18 (5 µm, 150 × 4.6 mm). An isocratic elution was applied using a mobile phase consisting of ethanol: water (50:50, v/v). A wavelength of 230.0 nm was chosen for the analysis. An experiment was finished 3.0 mins. Calibration graphs for each drug were rectilinear in the range of 0.1 – 40.0 µg/mL. Validation studies were carried out based on International Conference on Harmonization (ICH) recommendations. The student (t) test for means and the (F) test for standard deviations were used to compare the results. In this study, we utilized the ChlorTox Scale, Greenness Index, AGREE, GAPI, and NQS Indicator to comprehensively evaluate the environmental, safety, and sustainability aspects of analytical methodology, aligning our approach with the United Nations Sustainable Development Goals (SDGs). It can be applied to quality control, bioequivalence studies, and routine analysis.

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来曲唑环境友好型高效液相色谱测定方法的建立及验证评价

分析方法的绿色化在定量分析领域引起了人们的兴趣，以减少对环境的影响，提高分析人员的安全和健康。来曲唑（Letrozole， LTZ）已成为绝经后晚期乳腺癌患者标准的一线内分泌治疗药物。本文建立了绿色高效液相色谱法（HPLC），并对其进行了优化、验证和定量分析。实验在Inertsil ODS- 3®C18（5µm, 150 × 4.6 mm）上进行。采用由乙醇：水（50:50,v/v）组成的流动相进行等密度洗脱。选择波长230.0 nm进行分析。实验结束3.0 min。每种药物的校准图在0.1 ~ 40.0µg/mL范围内呈直线关系。验证研究是根据国际协调会议（ICH）的建议进行的。采用均值的学生(t)检验和标准差的(F)检验比较结果。在本研究中，我们利用氯毒素量表、绿色指数、AGREE、GAPI和NQS指标对分析方法的环境、安全和可持续性方面进行综合评估，使我们的方法与联合国可持续发展目标（SDGs）保持一致。它可以应用于质量控制、生物等效性研究和常规分析。

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