ABSTRACT
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 needed separate and dedicated chromatographic condition for its analysis. No Chromatography method has been reported yet for simultaneous estimation of FDC products of aspirin using the single chromatography condition.
Objectives
Hence, the multipurpose-HPTLC method was developed for simultaneous estimation of some FDC products of aspirin using enhanced analytical quality by design approach based on DoE and risk-based DMAIC principle to save solvent, cost and time of analysis.
Methods
The risk-based DMAIC process was carried out with identification of potential method risk parameters and their assessment using 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.
Conclusion
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 the multipurpose-chromatography for analysis of FDC products of aspirin.
Highlights
DoE and Risk-based DMAIC principle to development of the multipurpose-chromatography method. Application of the developed method for the estimation of eight different FDC products of aspirin
Analytical quality-by-design approach for sample treatment of BSA-containing solutions
