A RAPID STABILITY INDICATING RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF DABIGATRAN ETEXILATE MESYLATE IN CAPSULES

Abstract: The article aims at developing a rapid, sensitive, accurate, precise and linear stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) assay method and validate as per ICH guidelines for the estimation of Dabigatran etexilate mesylate in capsules. The optimized method employs a reverse phase column, Phenomenex Kinetex EVO C18 (250X4.6mm;5μ), a mobile phase of triethylammonium phosphate buffer (pH 2.0):methanol:acetonitrile in the proportion of 30:30:40 v/v, flow rate of 0.6ml/min and a detection wavelength of 254 nm using a UV detector. Optimized method separated all the forced degradant impurities from the drug peak. Dabigatran etexilate mesylate eluted at 3.73min and the linearity of the method was 10- 30μg/ml. The precision was exemplified by relative standard deviation of 1.25%. Percentage mean recovery was found to be in the range of 90‐110, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 1.09ng/ml and 3.32ng/ml respectively. Keywords: Dabigatran etexilate mesylate, stability indicating HPLC assay method development, validation.