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Validation of an HPLC-UV for Apixaban Stability-Indicating Study
Emna Bellaaj1, Ameni Elleuch2, Kaouthar Louati1,3
1Faculty of Pharmacy, Laboratory of Analytical Chemistry, University of Monastir, Monastir, Tunisia.
A new HPLC-UV method validates apixaban stability, showing it is stable under most conditions but less so under hydrolysis. This method is suitable for quality control of apixaban in liquid pharmaceutical forms.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Apixaban is a novel oral anticoagulant targeting factor Xa.
- Lack of official pharmacopoeial monograph for apixaban finished pharmaceutical form hinders stability studies.
Purpose of the Study:
- To validate a simple, stability-indicating analytical method using HPLC-UV for apixaban.
- To assess the stability of apixaban under various stress conditions.
Main Methods:
- High-Performance Liquid Chromatography with Ultraviolet detection (HPLC-UV).
- Utilized a C18 column with a gradient mobile phase of ammonium acetate and acetonitrile.
- Validated the method according to International Council for Harmonisation (ICH) guidelines.
Main Results:
- Apixaban demonstrated relative stability under thermal, oxidative, and UV stress.
- Apixaban exhibited lower stability under acidic and basic hydrolysis conditions.
- The developed HPLC-UV method proved to be specific, linear, accurate, and precise.
Conclusions:
- The validated HPLC-UV method is suitable for apixaban stability studies.
- The method is also appropriate for routine quality control of apixaban in liquid pharmaceutical formulations.
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