Development and validation of Stability Indicating HPLC method for estimation of Embelin in Embelia tsjeriam cottam(Vidanga)

Abstract

           Embelin, is an active phytoconstituent obtained from fruits of Embelia tsjeriam cottam, commonly known as Vidanga. A simple stability indicating HPLC method for the estimation of Embelin has been developed and validated as per ICH Q2A(R1). Sample was eluted using HiQsil C₈ (4.6mm×250mm) column. The mobile phase consisted of Methanol: Acetonitrile: 1% O-phospheric acid in water in the ratio of 70:15:15 v/v/v which was sonicated to degas and delivered at a flow rate of 1ml/min at ambient temperature. The retention time of Embelin was 6.05 ± 0.2 minutes. Studies were performed using an HPLC system equipped with a UV detector; the response was monitored at 291 nm. A good linear relationship over the range of 2–10 µg/ml concentrations with correlation coefficient value of 0.999 was obtained. The accuracy of the method is indicated by good recovery in the range of 98.9-101.2 % and precision less than 2% RSD. The limit of detection and limit of quantification were found to be 0.47 and 1.44µg/ml respectively. Embelin was subjected to stress conditions as per ICH Q2A(R2) and a significant degradation was found to occur by acid hydrolysis, oxidation and thermal stress. Stress degradation studies on embelin provide an insight into its stability.