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

  • Sweta V Kulkarni AISSMS college of pharmacy,Kennedy Road,Near RTO,Pune,Savitri bai Phule Pune University.
  • Mrinalini C Damle AISSMS college of Pharmacy,Near RTO,Kennedy road,Pune,Savitri bai Phule Pune University.
Keywords: Embelia tsjeriam cottam, Embelin, Stability indicating HPLC, Validation, stress degradation

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.

 

Author Biographies

Sweta V Kulkarni, AISSMS college of pharmacy,Kennedy Road,Near RTO,Pune,Savitri bai Phule Pune University.
Department of Quality Assuarance
Mrinalini C Damle, AISSMS college of Pharmacy,Near RTO,Kennedy road,Pune,Savitri bai Phule Pune University.
Department of Quality Assuarance
Published
2015-09-27
Section
Research Articles