Analytical Method Development and Validation of Rapid and Simple Stability- Indicating RP-HPLC Method for Determination of Fluindione in Bulk and Tablet Dosage Forms

Author(s): J.P. Srinivasa Reddy*, T. Parthasarathy, Chetan M. Bhalgat

Abstract: Fluindione is an oral anticoagulant drug. A rapid, simple, selective and precise method has been successfully developed and validated for the determination of Fluindione in bulk form and tablet dosage formulations. This method is based on HPLC separation followed by UV detection at 285 nm. HPLC method was developed on a Symmetry ODS (4.6 x 150 mm, 5μ) column with a mobile phase consisting of sodium phosphate buffer pH 3.5: Acetonitrile, 50:50 v/v, pumped at 1.0 mL/min 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 b y using PDA detector. Fluindione was eluted at 3.5 minutes. Stress degradation study shows that sample degraded with acid hydrolysis, base hydrolysis, Oxidation and thermal stress conditions. The method was validated in accordance with requirement of ICH guidelines for specificity, linearity, accuracy, precision, robustness and ruggedness.

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