Method Development and Validation of Dabigatran in Pharmaceutical Dosage Form by RP- HPLC Method

Abstract

A simple precise, accurate method was developed and validated by reversed phase high performance liquid chromatography method used for the estimation of Dabigatran in bulk and pharmaceutical dosage form. It is reversed phase liquid chromatography. The HPLC method has been carried out by using C18 150x4.6mm 5?m column. This method has been developed by using the mobile phase consisting buffer: Acetonitrile 65:35 and the flow rate of 1ml/min by the detection of UV at 330nm. The retention time of the dabigatran is 0.999 min. The runtime is 15min. the linearity was found to be over a concentration of 25%-150% respectively. The accuracy was found to be 98.84 to 100.24%. With a correlation coefficient of0.999.The proposed method can be used for the estimation of the drug in bulk and pharmaceutical formulation. The results of analysis have been validated satisfactorily using recovery studies.