Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form

Manoj Charde, A. S. Welankiwar

Abstract


A RP-HPLC method for the estimation of  ATN (Atenolol) and CTN (chlorthalidone) in combined dosage form was developed  using Comosil RP-C18 (4.6 x 250mm, 5µm) in an gradient mode with mobile phase comprising  of Methanol: Water (pH 3 using OPA) The flow rate was 1 mL/ min and effluent was monitored at 226.0 nm. The retention times were found to be 2.2 min for ATN and 3.36 min for CTN. The assay exhibited a linear dynamic range of 40- 200 µg/mL for ATN and 10- 50 µg/mL for CTN. The calibration curves were linear (r2 = 0.999 for ATN and r2 = 0.999 for CTN) over the entire linear range. Mean % recovery was found to be 99.78 % for ATN and 99.30 % for CTN with % RSD was NMT 2 for both estimations which fully agrees with system suitability which is in good agreement with labeled amount of formulation. The % RSD for Intra- Day & Inter-Day Precision was NMT than 2 for both the drugs. The developed method was validated as per ICH guidelines

Keywords


ATN, CTN, RP-HPLC, Assay method, Method ValidationATN, CTN, RP-HPLC, Assay method, Method Validation

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Copyright (c) 2014 International Journal of Advances in Pharmaceutics