Background Hypertension is a major health problem found in people throughout the world and numerous fixed-dose combination (FDC) products of telmisartan are available in the local market for its treatment. Several chromatography methods such as reversed-phase (RP)-HPLC and HPTLC methods have been published for estimation of FDC products of telmisartan with hydrochlorothiazide, atorvastatin, and amlodipine. No RP-HPLC method has been reported yet for synchronous estimation of FDC products of telmisartan, which would save analysis time, cost, and solvent. Objective A multipurpose RP-HPLC method has been developed for synchronous estimation of FDC products of telmisartan using the analytical quality by design approach based on risk- and design of experiment (DoE)-based define, measure, analyse, improve, control (DMAIC) principles. Method The risk-based DMAIC principle was implemented by risk parameter identification and assessment as per the ICH Q9 guideline. The DoE-based DMAIC principle was applied by response surface analysis using a Box-Behnken design. The method operable design ranges were navigated and a control strategy was set for the development of the method as per the analytical target profile (ATP). Results Chromatographic separation was performed using Shimpack ODS C18 column and acetonitrile: 0.1% (v/v) triethylamine (pH 6.5), keeping a flow rate of 1.0 mL/min. The method was validated as per the ICH Q2 (R1) guideline. The developed method was applied for synchronous estimation of seven different anti-hypertensive products. Conclusions The developed method is an eco-friendly and economical alternative to published chromatography methods for the analysis of anti-hypertensive products. Hence, the developed method can be used as a multipurpose RPLC method for quality control of anti-hypertensive products in the pharmaceutical industry. Highlights A multipurpose RPLC method for synchronous estimation of antihypertensive products of telmisartan was developed, saving analysis time, cost, and solvent. The developed method was applied to the synchronous estimation of seven different anti-hypertensive products.

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使用 AQbD 方法同步估计抗高血压药物的多用途 RP-HPLC 方法的风险和基于 DoE 的 DMAIC 原则

背景高血压是世界各地人们发现的主要健康问题，并且在当地市场上有许多替米沙坦固定剂量复方 (FDC) 产品用于治疗。已经发表了几种色谱方法，例如反相 (RP)-HPLC 和 HPTLC 方法，用于估计替米沙坦与氢氯噻嗪、阿托伐他汀和氨氯地平的 FDC 产物。目前还没有报道同步估计替米沙坦 FDC 产物的 RP-HPLC 方法，这将节省分析时间、成本和溶剂。目的 采用基于风险和实验设计 (DoE) 的定义、测量、分析、改进、控制 (DMAIC) 的分析质量设计方法，开发了一种多用途 RP-HPLC 方法，用于同步估计替米沙坦的 FDC 产品。原则。方法 根据 ICH Q9 指南，通过风险参数识别和评估，实施基于风险的 DMAIC 原则。使用 Box-Behnken 设计的响应面分析应用了基于 DoE 的 DMAIC 原理。导航方法可操作设计范围，并根据分析目标配置文件 (ATP) 为方法开发设置控制策略。结果 使用 Shimpack ODS C18 色谱柱和乙腈：0.1% (v/v) 三乙胺 (pH 6.5) 进行色谱分离，流速保持在 1.0 mL/min。该方法已根据 ICH Q2 (R1) 指南进行了验证。所开发的方法用于同步估计七种不同的抗高血压产品。结论 所开发的方法是用于分析抗高血压产品的已发表色谱方法的一种环保且经济的替代方法。因此，所开发的方法可用作制药行业抗高血压产品质量控制的多用途 RPLC 方法。亮点 开发了一种用于同步评估替米沙坦抗高血压药物的多用途 RPLC 方法，节省了分析时间、成本和溶剂。将所开发的方法应用于七种不同抗高血压产品的同步估计。亮点 开发了一种用于同步评估替米沙坦抗高血压药物的多用途 RPLC 方法，节省了分析时间、成本和溶剂。将所开发的方法应用于七种不同抗高血压产品的同步估计。亮点 开发了一种用于同步评估替米沙坦抗高血压药物的多用途 RPLC 方法，节省了分析时间、成本和溶剂。将所开发的方法应用于七种不同抗高血压产品的同步估计。