Analytical method development and validation of carvedilol in bulk and tablet dosage form by using uv spectroscopic method as per ich guidelines

Abstract

A simple, sensitive, highly accurate spectrophotometric method has been developed for the determination of carvedilol in bulk and pharmaceutical tablet dosage form as per ICH Guideliness. The adequate drug solubility and maximum assay sensitivity was found in methanol. The absorbance of carvedilol was measured at 241 nm in the wavelength range of 200‐400 nm. Beer’s law was obeyed in the concentration range of 10 -60 μg/mL, in the linearity study regression equation was found to be y = 0.183X -0.009& correlation coefficient was found to be 0.999. This method was Rugged and Robust in different testing criteria, LOD and LOQ wa s found to be 0.33 μg / ml & 1 μg / ml respectively. Accuracy study was done in 3 different concentration levels 50, 100, 150% & % recovery of the method was found to be 101.0%, 100.5%, 100.4% respectively in 3 different levels & mean recovery was 100.6%, so method was accurate. Results of all validation parameter were within the limit as per ICH guideline. Results of percentage recovery shows that the method was not affected by the presence of common excipients. The proposed method has been successfully us ed for the analysis of the drug in pure and its tablet dosage forms. Easily and the method was precise accurate to perform in future