Development and Validation of Aprocitentan Dosage Form and in Bulk Drug by UV Spectrophotometric Method

A simple, sensitive, accurate, rapid and economical U V Spectrophotometric method was developed and validated of Aprocitentan in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Dimethylsulfoxide as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.998. Limit of detection (LOD) was found to be 1.226µg/ml and Limit of quantitation (LOQ) was found to be 5.226µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.