Abstract
Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban.
 Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm.
 Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively.
 Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.
Highlights
Apixaban is an oral anticoagulant and direct inhibitor of factor Xa, which is used to decrease the risk of venous thrombosis, systemic embolization and stroke in patients with atrial fibrillation
Apixaban has been linked to a low rate of serum aminotransferase elevations during therapy and to rare instances of clinically apparent liver injury [1]
Apixaban was approved for the prevention of stroke, blood clots in patients with non-valvular atrial fibrillation on December 28, 2012 [3]
Summary
Apixaban is an oral anticoagulant and direct inhibitor of factor Xa, which is used to decrease the risk of venous thrombosis, systemic embolization and stroke in patients with atrial fibrillation. Apixaban has been linked to a low rate of serum aminotransferase elevations during therapy and to rare instances of clinically apparent liver injury [1]. Its molecular formula is C25H25N5O4 and molecular weight is 459.5 Apixaban was approved for the prevention of stroke, blood clots in patients with non-valvular atrial fibrillation on December 28, 2012 [3]. On March 14 2014 it was approved for the use of preventing deep vein thrombosis in adult patients who have undergone total knee or hip replacement surgery [4]
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