Enantiomeric Determination of Carvedilol by a Newly Developed and Validated Chiral HPLC Method
Keywords:
Carvedilol, method development, validation, content of enantiomers, enantiomeric purity.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.
