A high performance liquid chromatography method is used for the determination of dabigatran and its impurities in the presence of its degradation products using a reverse phase chromatography tech by C8 column at 30°C temperature with a mobile phase consisting of phosphate buffer and acetonitrile with gradient program. The flow rate was 0.8 ml/min. Quantification was achieved with UV detection at 220 nm based on maximum absorbance. The method was validated for specificity, linearity, accuracy, precision, sensitivity and robustness. The method was found to be suitable for the quality control of dabigatran in bulk drug and dosage form.
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