Polymorph screening development and validation of analytical method for estimation of selected antihypertensive drugs by aqbd approach

Abstract

ABSTRACT Background: Quality by Design (QbD) is a systematic approach to pharmaceutical development that focusses on process understanding and quality risk management, ensures reliable and high-quality analytical procedures. Antihypertensive drugs require precise quantification and employing QbD principles improves accuracy, sensitivity, and repeatability. DoE and optimization algorithms help in identifying critical factors that influence method performance, while validation as per ICH guidelines provides specificity, accuracy, and robustness. QbD simplifies regulatory compliance and improves pharmaceutical quality control. Further, polymorphic screening is an important aspect of pre-formulation studies during formulation development. Polymorphic from plays an important role in therapeutic efficacy. Objectives The main objective of this research is to develop, optimize, and validate QbD assisted analytical methods for the estimation of selected antihypertensive drugs, ensuring accuracy, precision, sensitivity, robustness, and regulatory compliance for routine quality control. Also, this research is aimed to prepare and characterize multicomponent polymorphs (Cocrystals) using advanced formulation techniques.