Development and Validation of the Reversed Phase UPLC Method for the Quantitative Estimation of Dabigatran Etexilate in Dabigatran Etexilate Capsules (Research Article)

Author(s): Sanjay S Shetgar*, K Basavaiah and B. M Rao

Abstract: Current work discloses development and validation of a simple, accurate, sensitive, and quick reverse phase ultra-performance liquid chromatograph (RP-UPLC) method for the quantitative estimation of Dabigatran Etexilate in Dabigatran Etexilate capsules. This development was achieved using a Waters Acquity UPLC with Hibar C18 column of dimensions 100 mm x 2.1 mm, 1.8μm column at 0.3 mL/min flow rate and Acquity TUV detector at 218 nm. This analytical UPLC method is validated based on the guidelines of the International Conference on Harmonization (ICH – Q2(R2), November 2005). Linearity was demonstrated in the range 25% to 150% levels with Coefficient of Determination (R2) value of 0.9999. Precision and Accuracy performed using the ICH guidance approach with recovery at 100.07%. The RP-UPLC method is sensitive with levels of Limit of detection (LOD) and Limit of Quantitation (LOQ) at 0.82μg/mL and 2.50μg/mL respectively. Degradation studies in conditions of Oxidation, Acid, Alkali, Thermal, Photostability and Water demonstrate no interference from the degradants. This simple, accurate, sensitive and quick RP-UPLC method for Dabigatran serves as an efficient tool in routine quality control and stability testing of Dabigatran and its formulations.

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