AN RP– UPLC METHOD DEVELOPMENT AND VALIDATION OF APIXABAN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

M.Rajasekaran; M.Purushothaman; Rajesh Asija

Volume : VII, Issue : IX, September - 2018

AN RP– UPLC METHOD DEVELOPMENT AND VALIDATION OF APIXABAN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

M. Rajasekaran, M. Purushothaman, Rajesh Asija

Abstract :

A simple and selective UPLC method is described for the determination ofApixaban. Chromatographic separation was achieved on Inertsil ODS 3V C18(150x4.6 ID) 5�mcolumn using mobile phase consisting of a mixture of Phosphate buffer: Acetonitrile (40 :60) with detection of 269 nm. Linearity was observed in the range 50–150 �g /ml for Apixaban (r² =0.999) for the amount of drug estimated by the proposed method was in good agreement with the label claim.

The proposed method was validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.