Blue applicability grade index assessment and response surface modelling to synchronous determination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate by HPTLC method

IF 3.4 Q2 PHARMACOLOGY & PHARMACY
Pintu Prajapati, Krutika Patil, Dhrumi Naik, Veera Shakar Pulusu, Anzarul Haque, Mohd Abul Kalam, Shailesh Shah
{"title":"Blue applicability grade index assessment and response surface modelling to synchronous determination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate by HPTLC method","authors":"Pintu Prajapati,&nbsp;Krutika Patil,&nbsp;Dhrumi Naik,&nbsp;Veera Shakar Pulusu,&nbsp;Anzarul Haque,&nbsp;Mohd Abul Kalam,&nbsp;Shailesh Shah","doi":"10.1186/s43094-025-00770-1","DOIUrl":null,"url":null,"abstract":"<div><p>Diabetes mellitus is major chronic disease found in human due to stressful lifestyle and bad food habit. Recently, the Central Drugs Standard Control Organization of India has approved combination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate for the management of diabetes mellitus. Numerous chromatographic methods have been published in the literature for estimation of these anti-diabetic drugs on individual basis and their combinations. But these chromatographic analyses promoted usage of toxic organic solvents which are harmful to the environment and aquatic animal lives. In addition, no chromatographic method was found in the literature for simultaneous estimation of these anti-diabetic drugs using green solvents. In recent days, white analytical chemistry approach has been introduced in the literature for development and assessment of green, accurate, precise, cost-effective and user-friendly chromatographic methods. Hence, white analytical chemistry-driven risk-based HPTLC method was developed for synchronous estimation of these anti-diabetic drugs using green solvents and response surface modelling. The analytical quality risk assessment was applied for identification of critical method variables and response variables using risk priority number ranking and filtering method. The critical method variables were linked with critical response variables using response surface modelling by Box–Behnken design. The analytical design space was navigated control strategy was framed for robust densitometric estimation of anti-diabetic drugs. The chromatographic method was validated as per ICH Q2 (R2) guideline. The developed method was applied for synchronous assay of multiple combinations of metformin, vildagliptin and dapagliflozin using single chromatographic condition to save time, cost and resources for analysis. The assay results of these anti-diabetic drug combinations were found to be complied with the respective labelled claim of the drugs. The developed and published chromatographic methods were assessed for their redness, greenness, blueness and whiteness profiles using green analytical metrics and RGB model scoring system. The proposed method was found to be green, cost-effective, robust and user-friendly for synchronous estimation of metformin, vildagliptin and dapagliflozin.</p></div>","PeriodicalId":577,"journal":{"name":"Future Journal of Pharmaceutical Sciences","volume":"11 1","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://fjps.springeropen.com/counter/pdf/10.1186/s43094-025-00770-1","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://link.springer.com/article/10.1186/s43094-025-00770-1","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Diabetes mellitus is major chronic disease found in human due to stressful lifestyle and bad food habit. Recently, the Central Drugs Standard Control Organization of India has approved combination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate for the management of diabetes mellitus. Numerous chromatographic methods have been published in the literature for estimation of these anti-diabetic drugs on individual basis and their combinations. But these chromatographic analyses promoted usage of toxic organic solvents which are harmful to the environment and aquatic animal lives. In addition, no chromatographic method was found in the literature for simultaneous estimation of these anti-diabetic drugs using green solvents. In recent days, white analytical chemistry approach has been introduced in the literature for development and assessment of green, accurate, precise, cost-effective and user-friendly chromatographic methods. Hence, white analytical chemistry-driven risk-based HPTLC method was developed for synchronous estimation of these anti-diabetic drugs using green solvents and response surface modelling. The analytical quality risk assessment was applied for identification of critical method variables and response variables using risk priority number ranking and filtering method. The critical method variables were linked with critical response variables using response surface modelling by Box–Behnken design. The analytical design space was navigated control strategy was framed for robust densitometric estimation of anti-diabetic drugs. The chromatographic method was validated as per ICH Q2 (R2) guideline. The developed method was applied for synchronous assay of multiple combinations of metformin, vildagliptin and dapagliflozin using single chromatographic condition to save time, cost and resources for analysis. The assay results of these anti-diabetic drug combinations were found to be complied with the respective labelled claim of the drugs. The developed and published chromatographic methods were assessed for their redness, greenness, blueness and whiteness profiles using green analytical metrics and RGB model scoring system. The proposed method was found to be green, cost-effective, robust and user-friendly for synchronous estimation of metformin, vildagliptin and dapagliflozin.

HPTLC法同步测定盐酸二甲双胍、维格列汀、达格列净丙二醇的蓝色适用性等级指数评价及响应面建模
糖尿病是由于生活方式紧张和不良饮食习惯导致的人类主要慢性疾病。最近,印度中央药品标准控制组织批准了盐酸二甲双胍、维格列汀和达格列净丙二醇一水联用治疗糖尿病。文献中已经发表了许多色谱方法来估计这些抗糖尿病药物的个体基础和它们的组合。但这些色谱分析促进了对环境和水生动物有害的有毒有机溶剂的使用。此外,文献中还没有发现使用绿色溶剂同时测定这些抗糖尿病药物的色谱方法。近年来,白色分析化学方法在文献中被引入,用于开发和评估绿色、准确、精确、成本效益和用户友好的色谱方法。因此,利用绿色溶剂和响应面建模,建立了基于白色分析化学驱动的基于风险的HPTLC方法,用于这些抗糖尿病药物的同步估计。采用风险优先级排序和过滤法,对关键方法变量和响应变量进行分析性质量风险评价。采用Box-Behnken设计的响应面模型将关键方法变量与关键响应变量联系起来。通过分析设计空间导航,构建了抗糖尿病药物稳健密度估计的控制策略。色谱方法按照ICH Q2 (R2)指南进行验证。该方法可用于二甲双胍、维格列汀和达格列净复合药物的单色谱同步检测,节省了分析时间、成本和资源。这些抗糖尿病药物组合的测定结果符合药物各自的标签声明。使用绿色分析指标和RGB模型评分系统对开发和发表的色谱方法的红、绿、蓝和白谱进行了评估。该方法具有绿色环保、成本效益高、鲁棒性好、用户友好等特点,可用于二甲双胍、维格列汀和达格列净的同步测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
44
审稿时长
23 weeks
期刊介绍: Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
×
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