Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

Gorja Ashok, Sumantha Mondal


A Stability Indicating Ultra-Performance Liquid Chromatography method was developed and
validated for quantification of Axitinib in tablets. The chromatographic separation was done
in an isocratic mode using the STD RP-18 Endcapped (50mm × 4.6mm, 2µ particle size)
column. The mobile phase 0.1% OPA and acetonitrile 55:45 (%v/v) at the flow rate of
0.2mL/min and at ambient temperature was used. The wavelength used for detection was
249nm. The retention time for Axitinib was found to 1.03min. Axitinib was linear in the
concentration range of 12.5µg/mL to 75µg/mL respectively. The developed method was
validated and found to be accurate, specific and robust. The drug was subjected to the stressed
conditions like acidic, basic, oxidative, photolytic, thermal and neutral conditions. The
degradation results are found satisfactory. This method can be applied for the estimation of
Axitinib in pharmaceutical dosage forms.


Axitinib, Stability-Indicating, UPLC, Method development, Validation.

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