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

IF 4.1 Q1 CHEMISTRY, ANALYTICAL
Hayam Mahmoud Lotfy , Asena Ayse Genc , M. Soner Bay , Gizem Tiris , Reem H. Obaydo , Nevin Erk
{"title":"Development of eco-friendly sensitive HPLC method for determination of Letrozole and assessment of validation","authors":"Hayam Mahmoud Lotfy ,&nbsp;Asena Ayse Genc ,&nbsp;M. Soner Bay ,&nbsp;Gizem Tiris ,&nbsp;Reem H. Obaydo ,&nbsp;Nevin Erk","doi":"10.1016/j.talo.2025.100425","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":436,"journal":{"name":"Talanta Open","volume":"11 ","pages":"Article 100425"},"PeriodicalIF":4.1000,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Talanta Open","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666831925000281","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0

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.

Abstract Image

求助全文
约1分钟内获得全文 求助全文
来源期刊
Talanta Open
Talanta Open Chemistry-Analytical Chemistry
CiteScore
5.20
自引率
0.00%
发文量
86
审稿时长
49 days
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信