DoE and Risk-Based DMAIC Principle for Implementation of Enhanced Analytical Quality by Design Approach to Multipurpose-Chromatography Method for Simultaneous Estimation of Multiple Fixed-Dose Combination Products of Aspirin.

BACKGROUND

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.

OBJECTIVE

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.

METHOD

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.

RESULTS

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.

CONCLUSIONS

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.

HIGHLIGHTS

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.