Simultaneous analysis of sacubitril and valsartan by novel analytical methods with green approach

Abstract

A novel high performance liquid chromatography (HPLC) and spectrophotometric analysis were applied for quantification of active substances of sacubitril (SAC) and valsartan (VAL). HPLC experiments were conducted on the Waters Spherisorb® (3.0 µm 60.0x4.0 mm) column. Preparation of mobile phase A: 200 mL of 0.1 % solution of trifluoroacetic acid in water and 800 mL of 0.1 % solution of trifluoroacetic acid in acetonitrile by volume are mixed. Preparation of mobile phase B: 800 mL of a 0.1 % solution of trifluoroacetic acid in water and 200 mL of 0.1 % solution of trifluoroacetic acid in acetonitrile by volume were mixed. It was given to the system at the ratio of Mobile Phase A: Mobile Phase B (35:65 v:v). The specimen was injected into the column at 15.0 µL. A detection wavelength of 254.0 nm was preferred for the compound and the flow rate was 2.0 mL/min. Analysis was completed in 4.0 min. The column oven temperature was adjusted to 40.0 °C. The methods were evaluated in terms of green chemistry. The methods have been validated according to ICH guidelines. For HPLC method calibration graphs were constructed in the 20.0– 145.0 and 20.0 – 155 µg/mL SAC and VAL respectively with an R2 of 1.000. In recovery experiments, the RSD values were calculated to be 0.08 % and 0.34 % for SAC and VAL, respectively. Additionally, in intraday and interday experiments, percent RSD values were found to be between 0.23 and 0.49. The method developed for the analysis of the active substances has been developed with a short analysis time and is cost effective. SAC and VAL were determined using a novel method for spectrophotometric analysis. The determination was performed simultaneously using the applied method. This method is a constant center method. Calibration graphs were constructed in the 2.0– 20.0 and 2.0 – 25 µg/mL SAC and VAL with an R2 of 0.9998 and 0.9999 respectively. It is a greenness method in terms of the analysis time and solvent used.