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.
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