Development and validation of stability indicating HPLC method for estimation of Dabigatran Etexilate Mesylate in drug substance

Abstract

Author(s): Badroon T andJ. Sreeramulu

A novel high speed, high resolution Reverse phase-HPLC method was developed for estimation of assay in Dabigatran etexilate mesylate drug substance. The separation of drug from the possible impurities was achieved on anInertsil C8 column. Ammonium formate buffer at pH 5.5 and acetonitrile mixture was selected as a mobile phase. Flow rate and detection were kept at 1.0 mL/min and 255 nm respectively. Column and sample compartmenttemperatures were maintained at ambient. Sample diluent was a mixture of buffer with acetonitrile. The developed HPLC method was subjected to validation parameters; Precision, Specificity, Linearity, Robustness, Ruggedness to comply withguidelines specifiedby ICH. Stability indicating nature of the method was also studiedby exposing the sample under various conditions like acid, base, peroxide and photo stability conditions.Using the method one can carry outquantitative estimation of assay in Dabigatranetexilate mesylate drug substance, further the same method can be adopted for determination of related substances also.