Development of carvedilol assay in tablet dosage form using HPLC with fluorescence detection

Abstract

A simple HPLC method was developed and validated for quantitation of carvedilol in dissolution medium and tablet dosage form. Chromatographic separation was achieved on a Alltima® C18 (250 mm4.6 mm) column using a mobile phase containing 0.01 M Na2HPO4 in water and acetonitrile (30:70 v/v) adjusted to pH 3.0 by ortho-phosphoric acid at a flow rate of 1.0 ml/min and employing fluorescence detection with 300- nm excitation and 343-nm emission wavelengths. The method was validated for specificity, linearity, accuracy, precision and stability. Dissolution test parameters were also investigated. Moreover, the proposed analytical method was applied to monitor the formulation content uniformity and labelled amount of commercially available carvedilol drugs.

Keywords

• carvedilol
• HPLC
• validation
• dissolution test
• quality control