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

Carvedilol (Fig.1.),or (±) –1- (carbazole – 4- yloxy)-3-[[2-(o-methoxyphenoxy) ethyl]amino]-2-propanol, is an antihypertensive agent with beta – and alpha -1-adrenergic receptor blocking activities 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 1.0mL/min was employed on L1 , 150 X 4.6, 5µ; Column, Column temperature 55 °C Run time: 60 min Injection size: 10μL mobile phase consisting of Potassium dihydrogen phosphate, dipotassium hydrogen phosphate and Acetonitrile in the ratio (50: 50 v/v) adjusted pH 3.0 with dilute phosphoric acid solution. The ultraviolet detection wavelength was at 240 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 0.8346µg/mL and 2.5292 µg/mL. The validated method can be successfully applied for the estimation of Carvedilol in pharmaceutical dosage forms.

کلیدواژه ها:

Carvedilol ، HPLC ، Validation ، Assay ، 240 nm