Abstract
A simple and rapid stability indicating HPLC method for Boceprevir was successfully developed and was validated. This method is based on HPLC separation followed by UV detection at 215 nm. HPLC method was developed on a symmetry Thermo C18 (250 x 4.6 mm i.d, 5 μm) column (sr no. 0860953Q) with a mobile phase consisting of methanol : 10mM di-sodium hydrogen phosphate buffer(pH 2.5):triethylamine 90:10:0.05 % v/v/v, pumped at 1.0 ml min-1 flow rate. The pH of buffer was adjusted to 2.5 with ortho phosphoric acid. The column was maintained at ambient temperature. The eluted compound was detected by using PDA detector. Boceprevir eluted at 3.33± 0.2 min. Stress degradation study shows that sample degraded with acid and base hydrolysis, under oxidation, thermal and photolytic stress conditions. The method was validated in accordance with requirement of ICH guidelines.
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