基于风险和试验设计的 DMAIC 原则在多用途反相高效液相色谱法中同步测定抗高血压药物的应用。
Risk and DoE-Based DMAIC Principle to the Multipurpose-RP-HPLC Method for Synchronous Estimation of Anti-Hypertensive Drugs Using AQbD Approach.
机构信息
Uka Tarsadia University, Maliba Pharmacy College, Department of Quality Assurance, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat-394 350, Gujarat, India.
出版信息
J AOAC Int. 2021 Sep 27;104(5):1442-1452. doi: 10.1093/jaoacint/qsab079.
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.
背景
高血压是全球范围内普遍存在的主要健康问题，许多地方市场都有治疗高血压的替米沙坦固定剂量复方制剂（FDC）产品。已经发表了几种色谱方法，如反相（RP）-HPLC 和 HPTLC 方法，用于估算替米沙坦与氢氯噻嗪、阿托伐他汀和氨氯地平的 FDC 产品。目前尚未报道用于同步估算替米沙坦 FDC 产品的 RP-HPLC 方法，该方法可以节省分析时间、成本和溶剂。
目的
基于风险和设计实验（DoE）的定义、测量、分析、改进、控制（DMAIC）原则，采用分析质量设计方法，开发了一种多用途 RP-HPLC 方法，用于同步估算替米沙坦 FDC 产品。
方法
按照 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。应用基于响应面分析的 DoE 基于 DMAIC 原则，采用 Box-Behnken 设计进行分析。根据分析目标概况（ATP），导航方法可操作设计范围并设置控制策略，以开发方法。
结果
使用 Shimpack ODS C18 柱和乙腈：0.1%（v/v）三乙胺（pH 6.5），流速为 1.0mL/min 进行色谱分离。方法按照 ICH Q2（R1）指南进行验证。该方法用于同步估算七种不同的抗高血压产品。
结论
与已发表的色谱方法相比，该方法是一种环保且经济的替代方法，可用于分析抗高血压产品。因此，该方法可作为制药行业抗高血压产品质量控制的多用途 RPLC 方法。
重点
开发了一种用于同步估算替米沙坦抗高血压产品的多用途 RPLC 方法，节省了分析时间、成本和溶剂。该方法已应用于七种不同抗高血压产品的同步估算。
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