Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers | Zendy

Amit Gosar | Zendy; Rajendra Phadke | Zendy; Deepesh Patil | Zendy; Kushal Gupta | Zendy; Prasad Thakur | Zendy

Open Access

Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers

Author(s) -

Amit Gosar,

Rajendra Phadke,

Deepesh Patil,

Kushal Gupta,

Prasad Thakur

Publication year - 2020

Publication title -

chemical and biomolecular engineering

Language(s) - English

Resource type - Journals

eISSN - 2578-8884

pISSN - 2578-8876

DOI - 10.11648/j.cbe.20200501.11

Subject(s) - apixaban , chromatography , dichloromethane , impurity , chemistry , correlation coefficient , analytical chemistry (journal) , mathematics , organic chemistry , medicine , statistics , solvent , rivaroxaban , warfarin , cardiology , atrial fibrillation

The purpose of this research study is to develop a novel, simple, precise, accurate and economical method for determination of Apixaban API isomers. Apixaban API has three isomer as ortho, meta and para. In reverse phase and normal phase chromatography it was very difficult to separate these isomer; hence new chiral technique was adopted. This chromatographic method was developed on chiralpak IA column (250×4.6×5µm) with isocritic technique. The detection of isomeric impurities were observed at wavelength 290nm. This analytical method was validated as per ICH guideline and regression analysis showed R value (correlation coefficient) > 0.999 for Apixaban API and its isomeric impurities. A solution of Apixaban in dichloromethane was found stable up to 48 hrs. The degradation study was done within the given guidelines prescribed by ICH. The method is validated for Linearity, Accuracy and Precision.

The content you want is available to Zendy users.

Already have an account? Click here to sign in.

Having issues? You can contact us here

Accelerating Research