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Title : STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RESIDUE OF ABIRATERONE BY HPLC
Authors : M. Ramesh Babu, V Umamaheswara Rao
Abstract : The purpose of the investigation was to develop a new RP-HPLC Method for estimation of Abiraterone in pharmaceutical dosage forms. Chromatography was carried out on an Symmetry shield RP-18, 250 mm x 4.6 mm, 5µm with a isocratic mobile phase composed of Buffer: mixture of solvent in the ratio of 10:90 % v/v (mixture of solvent of solvents in the ratio of Acetonitrile and Water in the ratio of 90:10 v/v) at a flow rate of 1.5 mL/min. The column temperature was maintained at 40°C and the detection was carried out using a PDA detector at 252 nm. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the International Conference on Harmonization guidelines. The retention time for Abiraterone was 7.20 min. The percentage recovery of Abiraterone was 101.65%. The relative standard deviation for assay of tablet was found to be less than 2%. The Method was fast, accurate, precise and sensitive hence it can be employed for routine quality control of tablets containing drugs in quality control laboratories and pharmaceutical industries.

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