Development of a Robust and Reliable RP-HPLC Method for the Estimation of Vericiguat in Tablet Dosage Form: Greenness Analysis using AGREE Penalties

Objectives

A simple and sensitive analytical method was developed to quantify the vericiguat in tablet formulation.

Materials and Methods

The analyte was separated on a Kromacil C column (250 mm×4.6 mm×5 μm particle size) using a mobile phase of potassium dihydrogen orthophosphate pH 2.5 adjusted with orthophosphoric acid and acetonitrile (50:50% v/v) pumped at 1.0 mL/min. Detection of the effluent was done using a UV detector at a wavelength of 252 nm.

Results

The retention time for vericiguat was 4.42 min. The drug showed linearity within the concentration range of 30-70 μg/mL. The accuracy of the method was considered satisfactory and the mean recovery percentage in the acceptable range of 99.92-100.61%.

Conclusion

The RP-HPLC method was successfully developed and validated according to ICH guidelines. The AGREE software was used to assess the environmental friendliness score of the proposed method, which was determined to be 0.79. The proposed method was simple, precise, sensitive, rapid, and robust for estimating vericiguat in tablets.