DEVELOPMENT & VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR THE DETERMINATION OF ZALTOPROFEN, A POTENT NSAID

A simple, rapid, stability indicating RP-HPLC method for the quantitation of Zaltoprofen was developed using water-alliance HPLC system equipped with PDA and UV Detectors. The Analysis performed using Inertsil ODS-2 column (150 x 4.6 mm, 5µm) as stationary phase and 45:55 v/v 0.01 M KH2PO4 Buffer (pH: 3.0) and Acetonitrile as mobile phase at a flow rate of 0.8mL/min for 30min. The effluent containing Zaltoprofen was detected with UV detector at 240 nm at ambient temperature. The method was validated as per ICH Guidelines with respect to system suitability, specificity, precision, sensitivity, accuracy, linearity, and robustness. Specificity is assessed by injecting all the stressed samples of Zaltoprofen were spiked with its three process impurities (0.15 % with respect to Zaltoprofen concentration). The method demonstrates that it provides excellent separation of Zaltoprofen from the impurities. Linearity was observed in the range from 50-150mcg/ml for with a correlation coefficient 0.999. Parameters of validation prove the precision and stability of the method and it’s applicability for the Assay of Zaltoprofen. The assay of Zaltoprofen was unaffected by the presence of its impurities and degradation products and thus confirms the stability-indicating power of the developed method. The method is suitable for routine analysis of