A simple reversed phase High Performance Liquid Chromatography method development and validation for determination of Carvedilol in pharmaceutical dosage forms

Abstract

A simple, sensitive and precise reverse phase high performance liquid chromatographic method has been developed for the estimation of Carvedilol in pharmaceutical preparations. Chromatographic determination was performed on a reversed phase C ₁₈ column (4.5 mm x 250 mm; 5 m particle size) using a mixture of Phosphate buffer: Acetonitrile (65:35) as mobile phase at a flow rate of 1ml/min with UV detection at 240 nm. The method was validated for linearity, accuracy, repeatability, precision, reproducibility, and specificity as per International ICH guidelines. The method was also used in determination Carvedilol content in five commercial brands available in Bangladeshi market. The method was linear in the range between 5 35 g/ml, exhibited good correlation coefficient (R ² = 0.998) and good Accuracy study (98.08 %-99.91%). The method was found to specific for Carvedilol in presence of common excipients. Statistical analysis performed with proposed method proved it to be precise, accurate and reproducible. Hence it can be employed for routine analysis of Carvedilol both in bulk and commercial formulations.