Quality by Design Approach for the Development and Validation of a Robust RP-HPLC Method for the Estimation of Aloe-Emodin

IF 0.7 4区医学 Q4 PHARMACOLOGY & PHARMACY

Current Pharmaceutical Analysis Pub Date : 2024-08-26 DOI:10.2174/0115734129330671240812063919

Muzammil Husain, Yogeeta O. Agrawal

{"title":"Quality by Design Approach for the Development and Validation of a Robust RP-HPLC Method for the Estimation of Aloe-Emodin","authors":"Muzammil Husain, Yogeeta O. Agrawal","doi":"10.2174/0115734129330671240812063919","DOIUrl":null,"url":null,"abstract":"Introduction/Objective: The current study examines the methodical Quality by Design (QbD) that facilitated the creation of an easy-to-use, quick, affordable, and stability-indicating reversed- phase high-performance liquid chromatography (RP-HPLC) technique for the efficient analysis of aloe-emodin. Methods: The chromatographic conditions were optimized with the Design Expert software 11.0 version, i.e., flow rate, buffer concentration, and column temperature. Results: The results of the linearity graph show R2 = 0.9988. The LOQ was 0.07949 μg/mL and the LOD was 0.02623 μg/mL. According to ICH rules, the technique validation parameters were within the allowed range. Utilizing the Design Expert 11.0 version, the Box–Behnken design experimental design explains the relationships between flow rate, buffer concentration, and column temperature at three distinct levels. The responses were monitored: the retention time (Rt), tailing factor (Tf), and number of theoretical plates (NTPs). Conclusion: The suggested approach was appropriate for quantitative determination and may be used in clinical pharmacokinetic investigations, biopharmaceutics, accredited testing laboratories, and quality control departments in enterprises.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.7000,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Pharmaceutical Analysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2174/0115734129330671240812063919","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction/Objective: The current study examines the methodical Quality by Design (QbD) that facilitated the creation of an easy-to-use, quick, affordable, and stability-indicating reversed- phase high-performance liquid chromatography (RP-HPLC) technique for the efficient analysis of aloe-emodin. Methods: The chromatographic conditions were optimized with the Design Expert software 11.0 version, i.e., flow rate, buffer concentration, and column temperature. Results: The results of the linearity graph show R2 = 0.9988. The LOQ was 0.07949 μg/mL and the LOD was 0.02623 μg/mL. According to ICH rules, the technique validation parameters were within the allowed range. Utilizing the Design Expert 11.0 version, the Box–Behnken design experimental design explains the relationships between flow rate, buffer concentration, and column temperature at three distinct levels. The responses were monitored: the retention time (Rt), tailing factor (Tf), and number of theoretical plates (NTPs). Conclusion: The suggested approach was appropriate for quantitative determination and may be used in clinical pharmacokinetic investigations, biopharmaceutics, accredited testing laboratories, and quality control departments in enterprises.

查看原文本刊更多论文

用 "质量源于设计 "方法开发和验证芦荟-艾莫丁的稳健 RP-HPLC 方法

引言/目的：本研究探讨了质量源于设计（QbD）的方法，该方法有助于创建一种易于使用、快速、经济实惠且稳定指示的反相高效液相色谱（RP-HPLC）技术，用于高效分析芦荟大黄素。方法：使用 Design Expert 软件 11.0 版优化色谱条件，即流速、缓冲液浓度和柱温。结果线性图结果显示 R2 = 0.9988。LOQ 为 0.07949 μg/mL，LOD 为 0.02623 μg/mL。根据 ICH 规定，技术验证参数在允许范围内。利用 Design Expert 11.0 版本，Box-Behnken 设计实验设计解释了流速、缓冲液浓度和色谱柱温度在三个不同水平上的关系。监测的反应包括：保留时间（Rt）、拖尾因子（Tf）和理论板数（NTP）。得出结论：建议的方法适用于定量测定，可用于临床药代动力学研究、生物制药、认证检测实验室和企业质量控制部门。

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

Current Pharmaceutical Analysis 医学-药学

CiteScore

1.50

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： Aims & Scope Current Pharmaceutical Analysis publishes expert reviews and original research articles on all the most recent advances in pharmaceutical and biomedical analysis. All aspects of the field are represented including drug analysis, analytical methodology and instrumentation. The journal is essential to all involved in pharmaceutical, biochemical and clinical analysis.