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

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.