Pintu B. Prajapati, Abhinandan Shahi, Aneri Acharya
Jul 21, 2022
Citations
0
Influential Citations
15
Citations
Journal
Journal of AOAC International
Abstract
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 analyst has to establish a separate chromatographic condition for the analysis of each FDC of AZL. No RP-HPLC method has been reported yet which 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 AQbD approach based on chemometric and DoE as per the upcoming 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 labelled claim of the FDCs. CONCLUSION The developed method requires less time, cost and organic solvent for analysis of the said pharmaceutical dosage forms as 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 (PCA and PLC) and DoE. Applications of the method for synchronous estimation of multiple FDCs of AZL.