Background:
Axitinib (AXT) is a member of the new generation of the kinase inhibitor
indicated for the treatment of advanced renal cell carcinoma. Its therapeutic benefits depend on assuring
the good-quality of its dosage forms in terms of content and stability of the pharmaceutically active
ingredient.
Objective:
This study was devoted to the development of a simple, sensitive and accurate stabilityindicating
high-performance liquid chromatographic method with ultraviolet detection (HPLC-UV)
for the determination of AXT in its bulk and dosage forms.
Methods:
Waters HPLC system was used. The chromatographic separation of AXT, internal standard
(olaparib), and degradation products were performed on the Nucleosil CN column (250 × 4.6
mm, 5 μm). The mobile phase consisted of water:acetonitrile:methanol (40:40:20, v/v/v) with a flow
rate of 1 ml/min, and the UV detector was set at 225 nm. AXT was subjected to different accelerated
stress conditions and the degradation products, when any, were completely resolved from the intact
AXT.
Results:
The method was linear (r = 0.9998) in the concentration range of 5-50 μg/ml. The limits of
detection and quantitation were 0.85 and 2.57 μg/ml, respectively. The accuracy of the method,
measured as recovery, was in the range of 98.0-103.6% with relative standard deviations in the range
of 0.06-3.43%. The results of stability testing revealed that AXT was mostly stable in neutral and oxidative
conditions; however, it was unstable in alkaline and acidic conditions. The kinetics of degradation
were studied, and the kinetic rate constants were determined. The proposed method was successfully
applied for the determination of AXT in bulk drug and dosage forms.
Conclusions:
A stability-indicating HPLC-UV method was developed and validated for assessing
AXT stability in its bulk and dosage forms. The method met the regulatory requirements of the International
Conference on Harmonization (ICH) and the Food and Drug Administration (FDA). The results
demonstrated that the method would have great value when applied in quality control and stability
studies for AXT.
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