Development and Validation of a Superior High Performance Liquid Chromatographic Method for Quantification of Axitinib in Solid Oral Dosage Form

A stability-indicating reversed phase high performance liquid chromatographic method was developed to quantify axitinib (AXT) in pharmaceutical dosage form. Chromatographic separation was achieved on a C-18 (250× 4.6 mm i.d., 5μm) column using 0.1% OPA: acetonitrile (55:45, v/v) as mobile phase at a flow rate of 1 mL.min -1 with a column temperature of 30° C and PDA detection at 210 nm. Establishment of calibration curve revealed linearity in the range of 12.5–75.0 μg.mL -1 along with values of accuracy and precision within the acceptance limit of mean percent recoveries between 98.7-100.3%. Limit of detection and limit of quantitation were found to be 0.06 and 0.17μg.mL-1. Analysis of system suitability revealed high degree of method reproducibility and robustness. The developed method showed high specificity for AXT and its degradation products formed during forced degradation conditions. The developed method also demonstrated suitability for routine analysis of AXT in bulk drug and pharmaceutical dosage forms.