Development and validation of HPLC method for determination of Carvedilol in API and pharmaceutical dosage forms

A simple, selective, linear, precise and accurate HPLC method was developed and validated for assay of Carvedilol in API and pharmaceutical dosage forms. Isocratic elution at a flow rate of ۱.۰mL/min was employed on L۱, ۱۵۰ X ۴.۶, ۵μ; Column, Column temperature ۵۵ °C Run time: ۶۰ min Injection size: ۱۰μL mobile phase consisting of Potassium dihydrogen phosphate, dipotassium hydrogen phosphate and Acetonitrile in the ratio (۵۰: ۵۰ v/v) adjusted pH ۳.۰ with dilute phosphoric acid solution. The ultraviolet detection wavelength was at ۲۴۰ nm. The method was validated for Linearity, Precision, Accuracy, Ruggedness and Robustness as per ICH Guidelines. The LOD and LOQ have also been established and found to be ۰.۸۳۴۶µg/mL and ۲.۵۲۹۲ µg/mL. The validated method can be successfully applied for the estimation of Carvedilol in pharmaceutical dosage forms.

Keywords:

Carvedilol , HPLC , Validation , Assay , ۲۴۰ nm