A QBD Approach Based RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Sacubitril-Valsartan Sodium Complex Salt in Its Synthetic Mixture

Abstract

A robust, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated using a Quality by Design (QbD) approach for the simultaneous estimation of dapagliflozin propanediol monohydrate and sacubitril–valsartan sodium complex in a synthetic mixture. Critical method parameters were systematically optimized through experimental design to ensure optimal separation, peak symmetry, and resolution. The chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase composition under isocratic conditions. The method demonstrated excellent linearity, precision, accuracy, and specificity within the tested concentration ranges. Validation was performed in accordance with regulatory guidelines, confirming the reliability of the method for routine analysis. The QbD framework enabled a thorough understanding of method variability and robustness, ensuring consistent performance. This developed method can be effectively applied for quality control and simultaneous quantification of these drugs in combined pharmaceutical formulations.