SEPARATION AND DETERMINATION OF PROCESS-RELATED IMPURITIES OF CELECOXIB IN BULK DRUGS USING REVERSED PHASE LIQUID CHROMATOGRAPHY

The present paper describes the development of a new isocratic reverse phase liquid chromatographic method for the separation and determination of celecoxib in the presence of its process-related impurities. The method was found to be simple, sensitive, precise, robust and accurate. Successful separation of the drug from the process impurities was achieved on an Inertsil ODS C18 column (250 mm X 4.6 mm, 5 µ) using phosphate buffer (pH adjusted to 3.5): acetonitrile (45-55v/v) as eluent, at a flow rate of 1.0 mL/min and the detection wavelength was set at 250 nm. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, humidity and thermal degradation. The degradation of celecoxib was observed under oxidative environment. The method was developed and validated with respect to specificity, system suitability, linearity, accuracy, precision, LOD (limit of detection), LOQ (limit of quantification) and robustness as per ICH (International Conference on Harmonisation) guidelines. Rezumat Lucrarea prezinta o noua metoda isocratica HPLC cu faze inversate pentru separarea și dozarea celecoxibului in prezența impuritaților sale. Metoda dezvoltata este simpla, sensibila, precisa, robusta și prezinta o inalta acuratețe. Metoda a fost validata conform normelor ICH(International Conference on Harmonisation) in vigoare.