Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF WARFARIN SODIUM CLATHRATE IN BULK AND PHARMACEUTIACAL DOSAGE FORM

Prasad V. Bhat, Manisha S. Phoujdar* and Swetal P. Vassa

ABSTRACT

The present work describes development and validation of a specific, sensitive, precise and stability-indicating high performance liquid chromatographic method of analysis of Warfarin Sodium Clathrate, as a bulk drug. The separation was achieved by using a mobile phase of acetonitrile: potassium acetate buffer 0.1 M pH 3.7 (60:40 v/v) and on a ‘Enable’ C-18 column (250 mm X 4.6 mm, 5 μm) at flow rate of 1.0 ml/min. The detection was done at 308 nm. The retention time of Warfarin Sodium Clathrate was 7.06±0.02 min. This method has been successively applied to pharmaceutical dosage form. No chromatographic interference from the tablet excipients was found. Warfarin Sodium Clathrate was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degraded products were well resolved from the pure drug with significantly different retention time values. Linearity was found to be in the range of 10– 60μg/ml with significantly high value of correlation coefficient. The method was validated for precision, robustness and recovery. The limit of detection and quantitation were 0.0424μg/ml and 0.1284μg/ml respectively.

Keywords: Warfarin Sodium Clathrate, HPLC Method development, Stress degradation, Validation, ICH guidelines.