DoE-Based Analytical-FMCEA for Enhanced AQbD Approach to MEER-RP-HPLC Method for Synchronous Estimation of 15 Anti-Hypertensive Pharmaceutical Dosage Forms

Abstract

Abstract Background In the recent scenario of green chemistry, the usage of organic solvents should be minimized in the development of analytical methods for the safety of the environment and analysts. Objective An RP-HPLC method has been developed as an economical and eco-friendly alternative to published RP-HPLC methods for the analysis of fixed-dose combinations (FDCs) of anti-hypertensive drugs, for saving time, resources, costs, and organic solvent. Methods The method has been developed through the implementation of an enhanced analytical quality by design (AQbD) approach using a design of experiment (DoE)-based analytical failure mode critical effect analysis (AFMCEA). The AFMCEA was performed by identifying potential analytical failure modes and assessing their risk using risk priority number ranking and filtering. The DoE-based AFMCEA was implemented for response surface analysis and mitigation of high-risk analytical failure modes by Box-Behnken design (BBD). The method operable design ranges and control strategy were set for lifecycle management of the developed method. Results The RP-HPLC method was developed using a Shimpack octadecyl silane (ODS) C18 column and acetonitrile–water (pH 6.2; 42:58 %, v/v). The method was validated as per ICH Q2 (R1) guidelines. The method was applied for the synchronous assay of 15 FDCs of anti-hypertensive drugs. Conclusion The developed method has fulfilled the requirements of numerous published RP-HPLC and HPTLC methods. Hence, this method is a multipurpose chromatography 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 FDCs of anti-hypertensive drugs in the pharmaceutical industry. Highlights Development of a MEER-RP-HPLC method for synchronous estimation of 15 pharmaceutical dosage forms of anti-hypertensive drugs. Implementation of an enhanced AQbD approach using a DoE-based AFMCEA to develop the method which was applied to the assay of 15 anti-hypertensive dosage forms.