Abstract

STABILITY-INDICATING HPTLC METHOD FOR QUANTITATIVE ESTIMATION OF DRONEDARONE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kshitija Kardile, Mrinalini C. Damle*

ABSTRACT

A stability-indicating high-performance thin layer chromatographic (HPTLC) method has been developed for the quantitative determination of Dronedarone hydrochloride, a drug widely used for the treatment of cardiac arrhythmias. An approach of the stress degradation was successfully applied for the development of stability indicating HPTLC method for the determination of Dronedarone hydrochloride on the plates precoated with silica gel 60 F254. The mobile phase used was Acetone: Methanol in the ratio of 8:2 v/v. The drug showed considerable absorbance at 288 nm. Stress testing of Dronedarone hydrochloride was carried out according to the international conference of harmonization (ICH) guideline Q1A (R2). The drug was subjected to hydrolysis under different pH conditions, oxidation, thermal degradation and photolysis. The peak homogeneity data of Dronedarone hydrochlorideis obtained by peak purity (by spectral comparison at start, middle and end of peak) parameter. The method was successfully validated according to ICH guidelines Q2 (R1). The linearity of the proposed method was found to be in the concentration range of 40-200 ng/band. Regression analysis showed a correlation coefficient value greater than 0.997. The accuracy of the method was established based on the recovery studies.

Keywords: Dronedarone hydrochloride, high-performance thin layer chromatographic (HPTLC) method, Stability-Indicating Method.