Mahesh G. Thakare

Fluindione is an oral anticoagulant drug. A simple and rapid and was validated stability indicating HPLC method for Fluindione was successfully developed and was validated. This method is based on HPLC separation followed by UV detection at 285 nm. HPLC method was developed on a Symmetry thermo C18 (4.6 x 250 mm) column with a mobile phase consisting of 10mM di-sodium hydrogen phosphate buffer pH 3.5: methanol 15:85 v/v, pumped at 1.0 ml min-1 flow rate. The pH of buffer was adjusted to 3.5 with ortho phosphoric acid. The column was maintained at ambient temperature and 20μl of solutions were injected. The eluted compound was detected by using PDA detector. Fluindione was eluted at 2.4 ± 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.