Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF APIXABAN? A REVIEW

*Gholap Shubham V., Mankar Someshwar D. and Dr. Dighe Santosh B.

ABSTRACT

HPLC may be a analytical chemistry technique wont to separate, establish and amount every part during a mixture. a straightforward and pre use correct reverse part HPLC methodology was developed for the determination of apixaban in bulk and its dose kind. Literature survey reveals that there are only a few HPLC Associate in Nursingd ultraviolet radiation methodology obtainable therefore this try has been created to develop an RP-HPLC method for estimation of apixaban. The chromatographical separation is generally achieved on C18 or Inertsil ODS column at a rate of flow of one. 0ml/min for time varied from ten min to forty min for various methodology. The separation was achieved at wavelength 225 nm-281 nm. principally water and acetonitrile or acetonitrile and buffer isused as a mobile part. Column and sample temperature set was close temperature. standard purity was concerning ninety nine. 8%. This methodology are easy, precise, accurate, precision, LOD, LOQ, etc as per the ICH guideline.

Keywords: Apixaban, System quality, Validation, RP-HPLC, ICH pointers.