Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR ANALYSIS OF AMIODARONE HYDROCHLORIDE AND ITS RELATED COMPOUNDS

Amit Gosar*, Deepesh Patil, Advait Avalaskar, Narendra Aarkashi, Samadhan Aware, Srinivasan Kuduva and Rajender

Abstract

The purpose of this research study is to develop a novel, simple, precise, accurate and economical method for determination of related substances in Amiodarone Hydrochloride API. Efficient chromatographic method was developed to separate nine impurities using Zorbax Eclipse XDB C-18 (150 x 4.6 x 5μm) column with isocratic program. The detection of all impurities was observed at 240nm. Regression analysis showed R2 value (correlation coefficient) > 0.999 for Amiodarone Hydrochloride and all its impurities. A solution of Amiodarone Hydrochloride in ACN:H2O (8:2) was found stable for 48 hrs. The degradation study was done within the given guidelines prescribed by ICH. Degradation was found to occur under Basic Stress Condition but Amiodarone Hydrochloride was stable to acidic and oxidative stress condition. The method is validated for Linearity, Accuracy and Precision.

Keywords: Amiodarone Hydrochloride, RP-HPLC, Isocratic, Validation.