DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF PROCESS RELATED AND DEGRADATION IMPURITIES OF BICALUTAMIDE IN TABLET DOSAGE FORMS

Palleshwar Rao G, JVLNS Rao, Lanka A. Rama Prasad and Srinivasu Pamidi

The present work aims to develop and validate a stability indicating liquid chromatographic method for the estimation of process related and degradation impurities of Bicalutamide in tablet dosage form. Chromatographic separation was achieved on Waters Symmetry C18, (150 mm x 4.6 mm) 3.5m particle size column using 0.1%v/v trifluoro acetic acid and 0.05%w/v sodium-1-octane sulphonic acid in water and 0.1%v/v trifluoroacetic acid in acetonitrile the ratio of 65:35 as mobile phase in isocratic elution mode. The analytes were monitored by a photo diode array (PDA) detector set at 270 nm and the flow rate was kept at 1.2mL/min. The method was validated in terms of Specificity, Precision, Ruggedness, Accuracy, Robustness and Linearity as per ICH guidelines.