Development and Validation of a Stability-Indicating RP-HPLC and UV Spectrophotometric methods for the Estimation of Fluindione in Bulk and Tablet Dosage Forms

Abstract

Fluindione is an oral anticoagulant. The aim of the present study was to develop a stability-indicating
HPLC and UV Spectrophotometric methods for the determination of fluindione in bulk and its solid
dosage forms. HPLC method was developed on a Symmetry (4.6 x 150 mm, 5 µm, Make: ODS)
column with a mobile phase consisting of sodium phosphate buffer pH 3.5: acetonitrile 50:50 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 analyte
was quantified spectrophotometrically at 285 nm. Fluindione eluted at 3.5 min. The method was
validated reaching satisfactory results for selectivity, precision and accuracy. Forced degradation
samples could be simultaneously evaluated, without interferences in the quantitative analysis. For the
spectrophotometric analysis, methanol was used as solvent and the wavelength of 285 nm was selected
for the detection. Both methods were found to quantify fluindione in bulk and its tablets accurately.
Statistical analysis by Student's t-test showed no significant difference between the results obtained by
the two methods. Therefore HPLC and UV methods presented the most reliable results for the
analyses of fluindione tablets.