A Stability-Indicating LC Assay Method for Bicalutamide

Isolation and characterization of process related impurities and degradation products of bicalutamide and development of RP-HPLC method for impurity profile study

“…From all above spectral information the structures of IV was confirmed as N-(4-cyano-3-trifluoromethyl-phenyl)-3-(4-fluoro-benzene sulfinyl)-2-hydroxy-2-methyl-propionamide. The process impurity IV matched with the impurity-B reported by Saravanan et al [15].…”

“…From the above spectral information the structures of compounds I and III were conformed as 3-(4-fluoro-benzenesulfonyl)-2-hydroxy-2-methyl-propionic acid and 4-amino-2-fluoromethyl-benzenonitrile, respectively. The degradation product III matched with the impurity-A reported by Saravanan et al [15]. The mechanism of degradation of BCT is given in Fig.…”

“…Under UV light, thermal and acidic conditions and in the presence of peroxide, no change in the sample purity was observed, but in alkaline conditions two degraded products (I and III) were formed and well separated from BCT under the present conditions (Fig. 11B) where as Saravanan et al [15] had reported only one of them (III). Further studies were carried out on the effect of concentration of the NaOH and temperature on kinetics of degradation.…”

“…In the present study a simple buffer 0.01 M KH 2 PO 4 (pH 3.0) was used in an isocratic mode for the separation. While the method reported by Saravanan et al was a gradient method and an ion pair reagent tetra n-butyl ammonium hydrogen sulphate was used as a mobile phase solvent [15]. Use of ion pair reagent decreases not only the column life time but also increases the time required for equilibration and an ion pair reagent in a gradient elution mode is not preferred because of system artifacts.…”

“…Recently we have also reported chiral HPLC method for the determination of BCT under thermal, photo, acidic, alkaline and peroxide conditions. Two degradation products were formed under alkaline conditions where as Saravanan et al [15] have reported only one of them. In the present study we also discussed the kinetics of degradation.…”