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Development and validation of RP-HPLC method for the assay of Celecoxib capsule

Journal: MIT International Journal of Pharmaceutical Sciences (MITIJPS) (Vol.2, No. 1)

Publication Date:

Authors : ; ;

Page : 22-26

Keywords : Celecoxib ? RP-HPLC ? ICH guidelines ? Validation;

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Abstract

Celecoxib is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1yl] benzene- 1-sulfonamide. A simple and accurate reversed phase liquid chromatography method (HPLC) method was developed for the quantitative estimation of celecoxib, a selective COX-2 inhibitor in capsule formulations. The drug was chromatographed on a reversed-phase C-18 column. Eluents were monitored at a wavelength of 220 nm using a mixture (600:400:1:1) of acetonitrile, Water, Triethylamine and Orthophosphoric acid. The retention time of Celecoxib was found to be 9.5 minutes. The flow rate of the mobile phase was 1.0 ml/min at room temperature. The percentage recovery lies in the range of 99.53%?99.75%. Solution concentrations were measured on a weight basis to avoid the use of an internal standard. The method was statistically validated for linearity, accuracy, precision, selectivity and intermediate Precision. Due to its simplicity and accuracy, we believe that the method will be useful for routine quality control analysis. The method was validated as per ICH guidelines.

Last modified: 2016-04-27 19:23:41