American Journal of Analytical Chemistry, 2015, 6, 437-445 Published Online April 2015 in SciRes. http://www.scirp.org/journal/ajac http://dx.doi.org/10.4236/ajac.2015.65043 How to cite this paper: Swetha, E., Vijitha, C. and Veeresham, C. (2015) HPLC Method Development and Validation of S(-)-Carvedilol from API and Formulations. American Journal of Analytical Chemistry, 6, 437-445. http://dx.doi.org/10.4236/ajac.2015.65043 HPLC Method Development and Validation of S(-)-Carvedilol from API and Formulations Ettireddy Swetha, Chandupatla Vijitha, Ciddi Veeresham * University College of Pharmaceutical Sciences, Kakatiya University, Warangal, India Email: * ciddiveeresham@yahoo.co.in Received 24 February 2015; accepted 9 April 2015; published 13 April 2015 Copyright © 2015 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ Abstract A simple chiral HPLC method was developed and validated for quantification of S(-)-Carvedilol in Active Pharmaceutical Ingredient (API) and marketed tablet formulation of racemic Carvedilol. Chiral resolution of enantiomers of Carvedilol was achieved on Phenomenex Lux-cellulose–4 (250 mm × 4.6 mm; 5 µ particle size) chiral column by using a mobile phase, Isopropanol and n-Heptane (60:40 v/v), at a flow rate of 1.0 ml/min and by employing UV detection at 254 nm wavelength. The method was validated according to the ICH guidelines and was proved to be specific, linear, precise and accurate for the analysis of S(-)-Carvedilol. Keywords S(-)-Carvedilol, Chiral HPLC, Chiral Resolution, API, Validation 1. Introduction Carvedilol, 1-(4-carbazolyloxy)-3-(2-(2-methoxy)ethylamino)-2-propanol [1], has an asymmetric carbon atom, which gives rise to S(-)- and R(+)-enantiomers [2]. It is a non-selective, β-adrenergic receptor antagonist and an α1-adrenoceptor blocker. Though the racemic mixture of Carvedilol is administered clinically, β-adrenoceptor blocking activity of the S(-)-enantiomer is about 200-fold higher than that of the R(+)-enantiomer while the α1-adrenoceptor blocking activity is same for both enantiomers [1]. In addition it is a powerful anti-oxidant; it can protect major organs like heart, kidneys, brain, vasculature, etc. from damage and hence is used in the treatment of chronic hypertension [3]. On oral dosing of racemic Carvedilol, the unbound fraction of S(-)-enan- tiomer is higher than that of the R(+)-enantiomer and hence S(-)- gets distributed predominantly in all tissues * Corresponding author.