ABSTRACT

The current paper describes a reversed phase high performance liquid chromatographic stability indicating assay method for the estimation of dabigatran hydrochloride in formulations. The separation was achieved on the LUNA C18 column 5? (250 x 4.6 mm id), using phosphate buffer (pH 3.6): methanol, 70:30 as the mobile phase at 1 ml/min flow rate and 226 nm as detection wavelength. The retention time of was found to be 5.317 min. The method was validated in terms of linearity, accuracy, precision, as per ICH Guidelines. The calibration curve was linear in the concentration range from 10-50 ?g/ml. The method was used for analyzing the concentration of dabigatran in capsule sample. Keywords: Dabigatran, Estimation, HPLC, Validation, ICH
Publication date: 01/05/2024

https://ijbpas.com/pdf/2024/May/MS_IJBPAS_2024_7986.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.5.7986