Comparative Estimation and Validation of Danicopan in Tablet Dosage Form and in Bulk Drug by Spectrophotometry Method

A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for Estimation and Validation of Danicopan pure drug and tablet dosage form. The absorbance was measured at 552.0nm using Dimethylsulfoxide as solvent system. It obeyed Beer’s law at the concentration range of 2–12μg/ml with coefficient of correlation (r2) of 0.996. Limit of detection (LOD was found to be 1.230μg/m land Limit of quantitation (LOQ) was found to be 5.230μg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness. It was also found that the excipients present in the commercial formulation did not interfere with the method. The proposed method can be utilized for routine quantitative analysis of Danicopan.