QBD APPROACH TO RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IVABRADINE FOR API AND PHARMACEUTICAL FORMULATION

The development and validation of a robust analytical method for Ivabradine estimation in APIs and pharmaceutical formulations are critical to ensuring drug quality and therapeutic efficacy. This study adopts a Quality by Design (QbD) approach to optimize and validate an RP-HPLC method for this purpose. Central Composite Design (CCD) was employed to evaluate the impact of key chromatographic parameters, including mobile phase composition and pH. A total of 13 experimental runs were conducted, and the optimal conditions were identified as a mobile phase consisting of methanol, acetonitrile, and phosphate buffer (35:35:30 v/v) at pH 4.0, using a C18 column. The method demonstrated high precision, accuracy, and robustness, with satisfactory retention times, asymmetry factors, and theoretical plate counts. Validation was performed per ICH guidelines, confirming the method's applicability for routine quality control and stability testing. This QbD-driven approach ensures compliance with regulatory standards while offering a reliable framework for analytical method development. Keywords: Quality by Design (QbD), RP-HPLC, Ivabradine, Analytical Method Validation, Central Composite Design (CCD), Chromatographic Optimization etc.