Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel GF₂₅₄ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.

如今，在质量风险管理（QRM）和实验设计（DoE）原理的基础上，在分析方法开发中通过设计方法实施质量已成为一项法规要求。因此，通过设计方法实现基于QRM和DoE的质量，已开发出一种精确，准确且可靠的高性能薄层色谱方法，用于同时估算阿齐沙坦美多美（AZM）和氯噻酮（CLT）。QRM通过识别可能的方法风险参数并通过分配风险优先级编号来进行评估。通过使用分辨率和拖尾因子作为关键方法属性，使用Design-Expert软件（试用版），通过Placket-Burman筛选设计和Box-Behnken响应面分析来实施DoE。根据分析目标配置文件（ATP）导航方法可操作设计区域（MODR）以开发方法。使用硅胶GF进行色谱分离₂₅₄为固定相，甲苯/甲醇/乙酸乙酯/甲酸（7：2：1：0.2，V / V）为双槽腔中的流动相，保持15分钟的饱和时间。根据国际协调大会第二季度（R1）指南对开发的方法进行了验证。所开发的方法用于测定AZM和CLT的组合药物剂型，结果与标记的权利要求非常一致。