Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF AMIODARONE HYDROCHLORIDE

Dr. Santosh, V. Gandhi* and Pooja R. Alli

Abstract

A simple, sensitive and accurate stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the estimation of Amiodarone hydrochloride in bulk and in pharmaceutical dosage form. The separation was performed on precoated silica gel 60 GF254 aluminum plates using Ethyl acetate: Methanol (9:1 v/v) as mobile phase. The retention factor (Rf) for drug was found to be 0.48 ± 2.05. The detection of band was carried out at 242 nm. The drug was subjected to different stress conditions like acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. The method was successfully validated according to ICH Q2 (R1) guidelines. The data of linear regression analysis indicated a good linear relationship over the concentration range of 200-1200ng/band with correlation coefficient (R2) 0.9976. The accuracy of the method was established based on the recovery studies. The developed method was found to be simple, sensitive, selective, accurate and repeatable for analysis of Amiodarone hydrochloride and can be adopted for routine analysis of drug in bulk and in pharmaceutical dosage form.

Keywords: High performance thin layer chromatography (HPTLC), Amiodarone hydrochloride, Stability indicating, Validation.