Development and Validation of A Green Ultra-Performance Liquid Chromatography (Uplc) Method for the Simultaneous Estimation of Sacubitril and Valsartan in Tablet Dosage Form: Assessment of Method Greenness

Abstract

Today, analysts prioritize environmental considerations when creating new analytical methods by emphasizing energy-efficient instruments, minimization of hazardous substances, and reduction of waste. The primary aim of this study was to develop and validate a simple, rapid, and eco-friendly Ultra-Performance Liquid Chromatography (UPLC) method for the simultaneous estimation of Sacubitril and Valsartan in tablet formulation in accordance with Green Analytical Chemistry (GAC) principles. Chromatographic separation was achieved on a Kromasil C18 column (250 mm × 4.6 mm, 5 µm particle size) using an optimized mobile phase of Methanol: Acetonitrile: Buffer (pH 3.0) in a ratio of 40:20:40 v/v/v. The analysis was performed at a flow rate of 1.0 mL/min with UV detection at 250 nm, achieving a total run time of 5.0 minutes. The developed RP-HPLC method was validated in accordance with International Council for Harmonisation (ICH Q2(R1)). Linearity was observed in the range of 6–36 µg/mL for Sacubitril and 6.5–39 µg/mL for Valsartan using six calibration levels. Recovery studies showed values between 98–102%, and precision was high with %RSD values less than 2 %. The greenness of the method was evaluated using Analytical Eco-Scale and Green Analytical Procedure Index (GAPI). The developed method is suitable for routine quality control while promoting sustainable laboratory practices.