A new stability--indicating RP-HPLC method to determine assay and known impurity of Celecoxib API.

A simple, rapid and accurate Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed to determine assay and known impurity of Celecoxib API. The chromatographic separation was performed on reversed-phase C-18 column. Eluents were monitored on photo-diode array detector at a wavelength of 254 nm using a mixture (40:60) of buffer and acetonitrile. Solution concentrations were measured on a weight basis to avoid the use of an internal standard. The method was statistically validated for forced-degradation study, linearity and range, accuracy, precision, stability of analytical solutions, and selectivity. Due to its simplicity, rapid, and accuracy, we believe that the method will be useful to determine assay and known impurity of Celecoxib.