Enantiomeric Determination of Carvedilol by a Newly Developed and Validated Chiral HPLC Method

Abstract

A new simple, selective, linear and accurate chiral HPLC method for assay of carvedilol enantiomers was developed with immobilized cellulose chiral stationary phases under normal-phase mode using hexane: isopropyl alcohol: diethyl amine: acetic acid (40: 60: 0.7: 0.3, v/v) as the mobile phase at a flow rate of 1.0 mL/min and detection at 220 nm. The method was validated for linearity, precision, accuracy, ruggedness, robustness and stability as per the guidelines of USP and ICH. The regression coefficients (r²) of the linearity were found to be 0.999 for both S- and R- carvedilol, detection limit (LOD) were 1.67 and 1.78 μg/mL and quantitation limit were also found to be 5.06 and 5.41 μg/mL for S- and R- carvedilol, respectively. The average percentage of recovery was found to be 99.59% to 100.83% for S- and 98.42% to 100.18% for R- carvedilol, respectively. The new method can be used for enantiomeric separation and estimation of carvedilol in pharmaceutical dosage forms without any interference.

Dhaka Univ. J. Pharm. Sci. 18(1): 61-68, 2019 (June)