Development and validation of RP-HPLC method for determination of carvedilol in bulk and pharmaceutical dosage forms

Research Article

K. Babu Naidu, M. Ram Mohan Re

Abstract

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for assay of Carvedilol in bulk drug and pharmaceutical dosage forms. Isocratic elution at a flow rate of 1mL/min was employed onHypersil ODS C18, 150 X 4.6, 5μ; Column, mobile phase consisting of Potassium dihydrogen orthophosphate, dipotassium hydrogen phosphate and Acetonitrile in the ratio (50: 50 v/v) adjusted pH 3.0 with diluteorthophosphoric acid solution. The ultraviolet detection wavelength was at 240nm. The method was validated forLinearity,Precision,Accuracy, Ruggedness and Robustness as per ICH Guidelines. The LOD and LOQ have also been established and found to be 0.8346μg/mL and 2.5292 μg/mL. The validated method can be successfully applied for the estimation of Carvedilol inpharmaceutical dosage forms.

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