Chemometric and Design of Experiments-Based Analytical Quality by Design and Green Chemistry Approaches to Multipurpose High-Pressure Liquid Chromatographic Method for Synchronous Estimation of Multiple Fixed-Dose Combinations of Azilsartan Medoxomil.

BACKGROUND

Azilsartan medoxomil (AZL) is an anti-hypertensive drug, and its numerous FDCs are used for the treatment of hypertension. Numerous chromatographic methods have been reported for the estimation of FDCs of AZL, but analysts have to establish a separate chromatographic condition for the analysis of each FDC of AZL. No reverse-phase high-pressure liquid chromatography (RP-HPLC) method has been reported yet that can be used for synchronous estimation of multiple FDCs of AZL.

OBJECTIVE

Hence, the RP-HPLC-PDA method has been developed for synchronous estimation of multiple FDCs of AZL to save time, cost, and solvent for the analysis.

METHOD

The RP-HPLC-PDA method has been developed by the implementation of the analytical quality by design (AQbD) approach based on chemometric and DoE as per the upcoming International Council for Harmonization (ICH) Q14 guideline.

RESULTS

The method was applied for synchronous estimation of multiple FDCs of AZL, and the assay results were found in compliance with the labeled claim of the FDCs.

CONCLUSIONS

The developed method requires less time, cost, and organic solvent for analysis of the said pharmaceutical dosage forms compared to published chromatographic methods. Hence, the developed method is green and multipurpose for the estimation of multiple FDCs of AZL.

HIGHLIGHTS

Development and validation of RP-HPLC method for synchronous estimation of multiple FDCs of AZL using chemometric (principal component analysis and PLS) and design of experiments (DoE). Applications of the method for synchronous estimation of multiple FDCs of AZL.