STUDY ON APPROACHES TO EXPEDITE AND SIMPLIFY FORCED DEGRADATION OF EPLERENONE

Abstract

In the present work, attempts were made to expedite conventional hydrolytic (acid, alkali, and wet heat) forced degradation with microwave oven and the use of factorial design to simplify it. Eplerenone was selected as the model drug for this study. With factorial design, two levels were selected and the main effect and interaction on degradation was statistically evaluated by using multiple regression equation and the surface response curve. Finally the experimental conditions were set to obtain optimum degradation. The degradation products formed were separated on C-18 column in reverse phase mode using LC. The degradation products generated under conventional and microwave-assisted method were compared with respect to retention time and molecular ion peak to make conclusion that microwave energy can be used to expedite hydrolytic forced degradation.

Keywords:

• eplerenone
• experimental design
• microwave-assisted forced degradation
• molecular ion peak
• surface response curve
• transformation

ACKNOWLEDGMENT

Authors are thankful to the trustees of Bhujbal Knowledge City, Nashik for providing necessary analytical facilities to carry out this work and Hetero Drug Laboratories, Hyderabad for providing gift sample of eplerenone.