A novel, simple, and precise RP-HPLC method has been developed for the quantitative analysis of Sacubitril and Valsartan using an Inertsil C18 column (150 × 4.6 mm, 3.5 µm) with a flow rate of 1 mL/min. The buffer was prepared with 2.5 g of hexane sulfonic acid and 1 mL of triethylamine, adjusted to pH 2.5 with orthophosphoric acid (OPA). The mobile phase consisted of a mixture of buffer and acetonitrile in a 70:30 ratio, and detection was performed at 224 nm.

Method validation was conducted according to ICH guidelines, evaluating parameters such as precision, accuracy, specificity, stability, robustness, linearity, limit of detection (LOD), and limit of quantification (LOQ), all of which were found to be within acceptable limits. Additionally, the LC-MS technique was employed for the characterization of degradation products.