Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF BICALUTAMIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

V. Rajashakar*, D. Bheemudu and V. Padma Bhushana Chary

Abstract

A specific, accurate and precise Reverse Phase High Performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of bicalutamide in bulk and tablet dosage forms. A Symmetry C18 (250 x 4.6 mm, 5μ) column with a moble phase of aetonitrile: water (90:10) was used. A flow rate of 0.5 ml/min was maintained. UV detection was performed at 270 nm. The retention time of bicalutamide was 6.15 min, and the total run time was 20 min. The method was validated as per ICH Q2 (R1) guidelines, for specificity, linearity, accuracy, precision, and robustness. The recovery of bicalutamide in tablets was found to be in the range 99-100.83%.

Keywords: Bicalutamide, HPLC, Validation.