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DoE-Based Analytical-FMCEA for Enhanced AQbD Approach to MEER-RP-HPLC Method for Synchronous Estimation of Fifteen Antihypertensive Pharmaceutical Dosage Forms
Journal of AOAC INTERNATIONAL  (IF1.913),  Pub Date : 2021-07-22, DOI: 10.1093/jaoacint/qsab097
Prajapati P, Patel A, Shah S.

Abstract
Background
In the recent scenario of green chemistry, the usage of organic solvent should be minimized in the development of the analytical method for the safety of the environment and analysts.
Objective
Hence, the RP-HPLC method has been developed as an economical and eco-friendly alternative to published RP-HPLC methods for the analysis of FDC of anti-hypertensive drugs to save time, resources, cost and organic solvent.
Method
The method has been developed by the implementation of an enhanced AQbD approach based on DoE-based AFMCEA. The AFMCEA was performed by identification of potential analytical failure modes followed by their risk assessment by RPN ranking and filtering method. The DoE-based AFMCEA was implemented for response surface analysis and mitigation of risk of high-risk analytical failure modes by BBD. The MODR and control strategy was set for lifecycle management of the developed method.
Results
The RP-HPLC method was developed using the Shimpack ODS C18 column and acetonitrile-water (pH 6.2) (42:58, %V/V). The method was found to be validated as per ICH Q2 (R1) guideline. The method was applied for the synchronous assay of fifteen FDC of antihypertensive drugs.
Conclusion
The developed method has fulfilled the requirements of numerous published RP-HPLC and HPTLC methods. Hence, this method is a multipurpose chromatography (M) method for synchronous estimation of FDC products of anti-hypertensive drugs. This method can be used as a multipurpose (M), economical (E), eco-friendly (E) and rapid (R), MEER-RP-HPLC for quality control of multiple FDC of anti-hypertensive drugs in the pharmaceutical industry.
Highlights
Development of MEER-RP-HPLC method for synchronous estimation of fifteen pharmaceutical dosage forms of anti-hypertensive drugs. Implementation of enhanced AQbD approach based on DoE-based AFMCEA in development of method and application of the method for assay of fifteen anti-hypertensive dosage forms.