Stability Indicating HPTLC Method for Estimation of Dabigatran Etexilate Mesylate in its Pharmaceutical Dosage Form

Abstract

Dabigatran etexilate mesylate is an anticoagulant drug. Dabigatran demonstrated its
efficacy for prophylaxis and treatment of thromboembolic event during orthopaedic
surgery and curative treatment of hypercoagulability in atrial fibrillation. The present study
deals with the development and validation of a stability-indicating high performance thinlayer chromatography (HPTLC) method for the estimation of Dabigatran etexilate mesylate
using TLC plates precoated with silica gel 60 F254 as stationary phase and toluene: ethyl
acetate: methanol: formic acid (3:4:3:0.2, v/v/v/v) as the mobile phase. The drug was
subjected to stress conditions such as hydrolysis, oxidation, photolysis, neutral and dry heat.
Degradation products produced as a result of the stress conditions did not interfere with
the detection of DEM, therefore the proposed method can be considered stabilityindicating. DEM showed degradation under hydrolytic, oxidative, photolytic and dry heat
conditions. DEM (Rf 0.47 ± 0.02) and its degradation products were well resolved. The
wavelength selected for quantitation was 314 nm. The method was linear in the
concentration range 50-250 ng/spot with a correlation coefficient of 0.9955. The %RSD for
repeatability of peak area measurement was found to be 0.62 and %RSD for repeatability
of sample application was found to be 0.75. The % RSD of intraday and interday precisions
were 0.91- 1.5 and 1.21- 1.7 respectively. The accuracy (recovery) was found to be in the
range of 99.45-100.37 %. The developed method was applied for assay of marketed
formulations and the results were found to be good agreement with labelled claim of
formulations