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Application of Quality Risk Assessment and DoE-Based Enhanced Analytical Quality by Design Approach to Development of Chromatography Method for Estimation of Combined Pharmaceutical Dosage Form of Five Drugs
Journal of Chromatographic Science ( IF 1.3 ) Pub Date : 2020-12-23 , DOI: 10.1093/chromsci/bmaa118
Pintu B Prajapati 1 , Kajal Jayswal 1 , Shailesh A Shah 1
Affiliation  

Abstract
The high-performance liquid chromatography method was only reported for simultaneous estimation of aspirin, simvastatin, ramipril, atenolol and hydrochlorothiazide in polycap capsule. High-performance thin-layer chromatography (HPTLC) method is now accepted as a method of analysis by many pharmaceutical industries and included as an official method in monographs of pharmacopeias of many countries. Hence, HPTLC method was developed and validated for the estimation of polycap capsule using enhanced analytical quality by design based on principles of quality risk management and design of experiment (DOE). Quality risk management was performed by the identification and assessment of risky method parameters. DoE was carried out by Placket–Burman screening design and Box–Behnken response surface methodology using resolution and tailing factor as critical method attributes. Method operable design region was navigated for optimization and development of the method. The developed method was validated as per ICH Q2 (R1) guideline. The method was found accurate, specific, precise and sensitive for the said estimation. The developed method was applied for the assay of polycap capsule and results were found in good agreement with the labeled claim. The developed method can be used as an alternative to reported HPLC methods for quality control of polycap capsule.


中文翻译:

质量风险评估和基于 DoE 的通过设计方法增强分析质量在开发用于估计五种药物组合药物剂型的色谱方法中的应用

摘要
高效液相色谱法仅被报道用于同时测定多囊胶囊中的阿司匹林、辛伐他汀、雷米普利、阿替洛尔和氢氯噻嗪。高效薄层色谱 (HPTLC) 方法现已被许多制药行业接受为一种分析方法,并被许多国家的药典专着列为官方方法。因此,基于质量风险管理和实验设计 (DOE) 的原则,开发并验证了 HPTLC 方法,以通过设计提高分析质量来估计 polycap 胶囊。质量风险管理是通过识别和评估有风险的方法参数来进行的。DoE 是通过 Placket-Burman 筛选设计和 Box-Behnken 响应面方法进行的,使用分辨率和拖尾因子作为关键方法属性。导航方法可操作设计区域以优化和开发方法。开发的方法根据 ICH Q2 (R1) 指南进行了验证。发现该方法对于所述估计是准确的、特异性的、精确的和灵敏的。将开发的方法应用于多囊胶囊的检测,结果与标签声明非常吻合。所开发的方法可用作已报道的 HPLC 方法的替代方法,用于对 polycap 胶囊进行质量控制。发现该方法对于所述估计是准确的、特异性的、精确的和灵敏的。将开发的方法应用于多囊胶囊的检测,结果与标签声明非常吻合。所开发的方法可用作已报道的 HPLC 方法的替代方法,用于对 polycap 胶囊进行质量控制。发现该方法对于所述估计是准确的、特异性的、精确的和灵敏的。将开发的方法应用于多囊胶囊的检测,结果与标签声明非常吻合。所开发的方法可用作已报道的 HPLC 方法的替代方法,用于对 polycap 胶囊进行质量控制。
更新日期:2020-12-23
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