Bicalutamide quantification in human plasma by high-performance liquid chromatography: Application to bioequivalence study

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A liquid chromatographic procedure was developed for the determination of a new anticancer agent bicalutamide in plasma using fluorescence detection. Chromatography was performed using a reversed phase trimethylsilyl bonded silica column with a mobile phase of water: acetonitrile (30:70) at a flow rate of 1 ml/min. Detection of the eluted peaks was observed using excitation and emission wavelengths of 272 and 328 nm, respectively. Chromatographic run time did not exceed 10 minutes with no interference of endogenous material. The calibration curve was linear over the concentration range of 0.05 to 0.8 ng/μl and inter – and intra – assay imprecision was less than 10%. The lower limit of quantitation was assessed at 0.03 ng/μl.

Bicalutamide; HPLC; Fluorescent detector; Bioequivalance studies