Uka Tarsadia University, Maliba Pharmacy College, Department of Quality Assurance, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat-394 350, Gujarat, India.
J AOAC Int. 2021 Sep 27;104(5):1430-1441. doi: 10.1093/jaoacint/qsab058.
Numerous RP-HPLC and HPTLC methods have been reported for estimation of fixed-dose combination (FDC) products of aspirin with anti-hypertensive and anti-lipidemic drugs. Each FDC of aspirin needs separate and dedicated chromatographic conditions for analyses. No chromatographic method has been reported for simultaneous estimation of FDC products of aspirin using a single chromatography condition.
A multipurpose HPTLC method was developed for simultaneous estimation of some FDC products of aspirin using an enhanced analytical quality-by-design approach based on a design of experiment (DoE) and risk-based define, measure, analyse, improve and control (DMAIC) principle to save solvent, cost, and time of analysis.
The risk-based DMAIC process was carried out with identification of potential method risk parameters and their assessment using risk priority number (RPN) ranking and filtering. The DoE-based DMAIC process was carried out by the implementation of fractional factorial and full factorial design.
The mobile phase composition and volume of modifier were found to be critical method risk parameters for resolution of all peaks. The developed method was found to be validated, and assay results of all FDC products of aspirin were found to be in good agreement with their respective labelled claim.
The developed method is found to be solvent, cost, and time saving and also fulfilled the analytical requirements of many reported chromatography methods. Hence, the developed method is a multipurpose chromatography for analysis of FDC products of aspirin.
DoE and risk-based DMAIC principle to development of the multipurpose-chromatography method. The developed method was applied for the estimation of eight different FDC products of aspirin.
已经有许多 RP-HPLC 和 HPTLC 方法被报道用于估计阿司匹林与抗高血压和抗血脂药物的固定剂量组合（FDC）产品。每个 FDC 的阿司匹林都需要单独和专用的色谱条件进行分析。没有报道过使用单一色谱条件同时估计阿司匹林的 FDC 产品的色谱方法。
开发了一种多用途的 HPTLC 方法，用于使用增强的分析质量设计方法（基于实验设计（DoE）和基于风险的定义、测量、分析、改进和控制（DMAIC）原则）同时估计阿司匹林的一些 FDC 产品，以节省溶剂、成本和分析时间。
进行基于风险的 DMAIC 过程，识别潜在的方法风险参数，并使用风险优先数（RPN）排名和筛选进行评估。基于 DoE 的 DMAIC 过程通过实施部分因子和全因子设计进行。
发现流动相组成和改性剂体积是分辨率所有峰的关键方法风险参数。所开发的方法被发现是经过验证的，并且所有阿司匹林的 FDC 产品的测定结果与各自的标签声称相符。
所开发的方法被发现是节省溶剂、成本和时间的方法，并且还满足了许多报道的色谱方法的分析要求。因此，所开发的方法是一种用于分析阿司匹林的 FDC 产品的多用途色谱方法。
DoE 和基于风险的 DMAIC 原则用于开发多用途色谱方法。所开发的方法用于估计八种不同的阿司匹林 FDC 产品。
