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ICH Harmonised Tripartite Guideline (2005) Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, 2005, 1-13.

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• TITLE: HPLC Method Development and Validation of S(-)-Carvedilol from API and Formulations

  AUTHORS: Ettireddy Swetha, Chandupatla Vijitha, Ciddi Veeresham

  KEYWORDS: S(-)-Carvedilol, Chiral HPLC, Chiral Resolution, API, Validation

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.6 No.5, April 13, 2015

  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.