HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF AXITINIB IN TABLET DOSAGE FORM
Narottam Pal*, Tayyaba Mahtab, Sumaiyya Saleem, Sayeeda Tabasum and A. Srinivasa Rao
ABSTRACT
A simple, accurate, rapid and precise isocratic reverse phase high performance liquid chromatographic method has been developed and validated for the determination of Axitinib in tablet dosage form. The chromatographic separation was carried out with a discovery analytical column (250×4.6mm, 5μm), a mixture of 0.1% ortho phosphoric acid: acetonitrile in the ratio of 55:45 as mobile phase, at a flow rate of 1.0 ml/minute maintaining the temperature at 30ºc. UV detection was performed at 322 nm. The retention times were 2.537for Axitinib. The method was validated according to ICH guidelines and the acceptance criteria of results for accuracy, precision, linearity, robustness, limit of detection, limit of quantification and ruggedness were met in all cases. The % RSD values for Axitinib in precision study was found to be 0.41%. The linearity of the calibration curve for analyte in the desired concentration range was good (r2>0.999). The high recovery and value of low relative standard deviation confirm the suitability of the method for routine evaluation of Axitinib in pharmaceutical dosage forms.
Keywords: Axitinib, HPLC, Method development, validation.
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