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Title : DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF PROCESS RELATED AND DEGRADATION IMPURITIES OF BICALUTAMIDE IN TABLET DOSAGE FORMS
Authors : *Palleshwar Rao G, JVLNS Rao, Lanka A. Rama Prasad and Srinivasu Pamidi
Abstract : 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) 3.5&#61549;m 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.<br />

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