Quantification of anticoagulant drug substance of Dabigatran Etexilate by avalidated Ultra performance liquid chromatographic method with detailedforce degradation study

The aims of this study to develop a method and validated it for Dabigatran etexilate which is used as an anticoagulant agent. Here we reported sensitive, precise, an accurate and time saving stability indicating methods performed on UPLC. The study was performed using HSS C18 (50 x 2.1 mm i.d.) column having 1.8 µm particle size, with buffer: acetonitrile (50:50 v/v) mobile phase. The assay method was carried out at 225 nm wavelength with PDA detector. The method was validated using parameters such as accuracy, precision, linearity, robustness, solution stability and degradation in different stress conditions.

Author(s): Ravi V. Ghediya, Madhavi Patel, Darshana Pandya, Anamik K. Shahand Ranjan C. Khunt

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