An experimental combination of analytical quality by design and green analytical chemistry approaches is introduced to develop an high-performance thin-layer chromatography (HPTLC) approach to quantify barnidipine hydrochloride in the pharmaceutical matrix. The analytical quality by design approach was introduced to green analytical chemistry to enhance protocol knowledge while ensuring efficiency and reducing environmental impacts, energy consumption and analyst visibility. This analytical approach was systematically addressed by exploring failure mode effect analysis, risk assessment and optimization design. Subsequently, a screening of primary variables was performed to select the aptest proportion of solvents in the mobile phase resulting from the principles of green analytical chemistry. Failure mode effect analysis and a risk assessment study were attempted to estimate the critical method parameters (CMPs). The influence of the CMPs on critical analytical attributes, i.e. retention factor and peak area, was assessed through a screening design. A response surface methodology was then executed for the critical analytical attributes as a concern of the determined CMPs, and the conditions for excellent resolution were determined using a desirability procedure. The established protocol was validated in compliance with the International Conference on Harmonization guideline Q2(R1) and showed excellent specificity and sensitivity.

中文翻译：

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通过设计和绿色分析化学方法探索分析质量的实验组合，以开发用于分析盐酸巴尼地平的 HPTLC 光密度协议

引入了设计分析质量和绿色分析化学方法的实验组合，以开发一种高效薄层色谱 (HPTLC) 方法来量化药物基质中的盐酸巴尼地平。将分析质量设计方法引入绿色分析化学，以增强协议知识，同时确保效率并减少对环境的影响、能源消耗和分析人员的可见性。通过探索失效模式影响分析、风险评估和优化设计，系统地解决了这种分析方法。随后，根据绿色分析化学的原理，对主要变量进行了筛选，以选择流动相中最合适的溶剂比例。尝试进行失效模式影响分析和风险评估研究来估计关键方法参数 (CMP)。通过筛选设计评估了 CMP 对关键分析属性（即保留因子和峰面积）的影响。然后对关键分析属性执行响应面法，作为确定的 CMP 的关注点，并使用合意性程序确定出色分辨率的条件。已建立的方案经验证符合国际协调会议指南 Q2(R1)，并显示出出色的特异性和敏感性。然后对关键分析属性执行响应面法，作为确定的 CMP 的关注点，并使用合意性程序确定出色分辨率的条件。已建立的方案经验证符合国际协调会议指南 Q2(R1)，并显示出出色的特异性和敏感性。然后对关键分析属性执行响应面法，作为确定的 CMP 的关注点，并使用合意性程序确定出色分辨率的条件。已建立的方案经验证符合国际协调会议指南 Q2(R1)，并显示出出色的特异性和敏感性。