Method development and method validation of udenafil in bulk and pharmaceutical dosage form by UV– spectrophotometric method

Abstract

A simple, precise and accurate UV Spectrophotometric method has been developed for estimation of udenafil in bulk and tablet dosage form. In this method udenafil shows λmax at 291nm using 0.1N HCl as a solvent. The responses were linear in the range of 5-35μg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y = 0.026x + 0.001 and 0.9999 respectively. The recovery of the drug from the sample was ranged between 98.47% and 100.00%. The proposed method was validated as per ICH Q2 (R1) guidelines for precision, linearity, accuracy and recovery. The %RSD values for both intraday and interday precision were less than 2.0. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.102μg/ml and 0.308μg/ml respectively by simple UV spectroscopy.