Novel Isocratic HPLC Method for Simultaneous Estimation of Sacubitril and Valsartan in Bulk and Formulation

Abstract In compliance with ICH requirements, a new selective, precise, and accurate reverse-phase High-Performance Liquid Chromatographic method for valsartan and sacubitril quantification was developed and validated. Eluents were detected at 284 nm. The HPLC method was designed utilizing a C18, (150mm × 4.6mm, 3.5μm) column with 1% Acetic acid in water: Methanol (45:55 v/v) as a mobile phase at a flow rate of 0.8 mL/min. For valsartan and sacubitril, the calibration curves were linear over the concentration range of 10 to 100 ng/mL (R2 = 1) and 20 to 140 ng/mL (R2 = 1), respectively. Valsartan and sacubitril were shown to have average retention times of 5.79 and 7.019 minutes, respectively. Valsartan and sacubitril had average percentage recoveries of 99.83± 0.14 and 100.06± 0.19 percent, respectively. Valsartan and sacubitril had respective LOD values of 0.0958 and 0.1059 ng/mL. The suggested method's intraand inter-day precision values (% RSD) were under 2%. For the simultaneous measurement of valsartan and sacubitril, a straightforward, exact, accurate, linear, and quick RP-HPLC technique was created and verified by ICH recommendations. The findings imply that the devised approach can be used for pharmaceutical formulation and routine bulk measurement of valsartan and sacubitril. The method’s applicability was confirmed through successful analysis of pharmaceutical formulations, indicating its potential utility for routine quality control and stability testing of Sacubitril and Valsartan in combined dosage forms. The choice of gradient elution, despite its complexity, was justified by the need for improved separation and resolution, which are critical for the accurate determination of these therapeutic agents.