Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND FORCED DEGRADATION STUDIES OF ELLAGIC ACID

Manisha S. Phoujdar*, Pranita S. Magar and Shwetal 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 Ellagic acid, as bulk drug and from inhouse tablet formulation. The separation was achieved by using a mobile phase of Phosphate buffer: Acetonitrile: Methanol 10mMPhosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mMPhosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM Phosphate buffer: Acetonitrile: Methanol 10mM pH2.6 (5:55:40 v/v) pH2.6 (5:55:40 v/v) pH2.6 (5:55:40 v/v) on a ‘Enable’ C-18 column (250 mm X 4.6 mm, 5 μm) at flow rate of 0.6ml/min. The detection was done at 254nm. The retention time of Ellagic acid was 4.91±0.02 min. This method was Successively applied to pharmaceutical dosage form. No chromatographic interference from the tablet excipients was found. Ellagic acid was subjected to stress conditions of hydrolysis, oxidation, alkaline and acidic 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 0.8-2.8μg/ml with significantly high value of correlation coefficient. The method was validated for precision, robustness and recovery. The limits of detection and quantitation were 0.0500μg/ml and 0.1518μg/ml respectively.

Keywords: Ellagic acid, Inhouse formulation, Stress degradation, Validation, ICH guidelines.