METHOD DEVELOPMENT AND VALIDATION OF APIXABAN USING RP-HPLC METHOD AND ITS STRESS STABILITY STUDIES

rayanni soundharya

Abstract


A simple, fast and precise reverse phase high performance liquid chromatographic method (RP-HPLC) good sensitivity was determined for the development and validation of Apixaban.In Water Apixabanλmax was fixed as 259nm using a Shimadzu UV-Visible spectrophotometer. The chromatographic separation was achieved on a Waters C18 column, 15µm, 4.6 x 250 mm as stationary phase with mobile phase comprising of water: Acetonitrile as a mixture in the ratio of 50:50 in an isocratic elution mode at 1.0mL/min flow rate and maintaining column temperature at ambient. The detection was monitored at 259nm for Apixaban. The retention time of Apixaban were found to be 3.4mins respectively. The linearity was found to be in the range of 5-2 μg/ml.The calibration factor is 0.999.Apixaban was subjected to photolytic, acidic, basic, oxidative, and thermal degradation. The drug was found to be stable in all the conditions. The developed method was simple, accurate, precise, specific, sensitive and reproducible. Stress testing should be given importance for quantification of degraded products of drugs helps us to maintain the quality, safety and efficacy of drugs in formulations.

 


Keywords


Apixaban, Spectrophotometric method, Method development, Validation.

References


https://www.drugbank.ca/drugs/DB06605

http://www.rxlist.com/eliquis-drug.html

Prabhune SS, Jaguste RS, Kondalkar PL, Pradhan NS. Stability-indicating high-performance liquid chromatographic determination of apixaban in the presence of degradation products. Scientia pharmaceutica. 2014 May 22;82(4):777-86.

Delavenne X, Mismetti P, Basset T. Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: application to pharmacokinetic study. Journal of pharmaceutical and biomedical analysis. 2013 May 5;78:150-3.

Baldelli S, Cattaneo D, Pignatelli P, Perrone V, Pastori D, Radice S, et al. Validation of an LC–MS/MS method for the simultaneous quantification of dabigatran, rivaroxaban and apixaban in human plasma. Bioanalysis. 2016 Feb;8(4):275-83.

El-Bagary RI, Elkady EF, Farid NA, Youssef NF. Validated spectrofluorimetric methods for the determination of apixaban and tirofiban hydrochloride in pharmaceutical formulations. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2017 Mar 5;174:326-30.

Gouin-Thibault I, Flaujac C, Delavenne X, Quenet S, Horellou MH, Laporte S, et al. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. Thrombosis and haemostasis. 2014;111(2):240-8.

Gurdeep Chatwal and Sham Anand, Instrumental methods of chemical analysis, 1st Edition, Himalaya publishing House, Delhi, 1999.

Synder LR and Kirkland JJ, Introduction to modern liquid chromatography, Wiley interscience, New York, 1979.

ICH harmonized tripartite guideline, Text on validation of analytical procedures, Recommended for adoption at step 4 of the ICH process by the ICH steering committee

International Conference on Harmonization: Guidelines of Photostability testing of new drug substances and Products (Q1B), 1996

ICH Guideline, Q2 (R1), Validation of Analytical Procedures, Text and Methodology, November 2005




URN: https://pmindexing.com/journals/index.php/IJCPA/issue/view/urn:pmi:jr:0011ijcpa.v5i1.13779

Refbacks

  • There are currently no refbacks.