Abstract
A Reverse phase-Ultra Performance liquid chromatography (RP-UPLC) method was developed and validated for the quantification of process and degradant impurities present in Dabigatran etexilate mesylate capsules. Degradation data in each condition shows that peaks are pure and method is found to be stability indicating in nature. Impurities are well separated at satisfactory level in Acquity High strength silica (HSS)-T3, 100 mm length x 2.1 mm ID, Octadecyl column with 1.8μ particle size. Mobile phase-A consists of 0.1% Orthophosphoric acid in water adjusted the pH to 3.5 with triethyl amine. Acetonitrile used as Mobile phase-B. Gradient elution mode has been chosen to elute all impurities of Dabigatran etexilate which are having different polarities. Finalized flow rate was 0.18 mL.min‒1 with a quantification wavelength of 290 nm. The developed method was successfully validated for specificity, linearity, precision, accuracy, determination of LOD, LOQ and robustness as per International conference on harmonization (ICH) general guidelines requirement. The validated method is useful for quantitative determination of impurities of Dabigatran etexilate in Dabigatran etexilate capsules dosage form, which enables to identify the therapeutic efficacy at reduced run time.
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