A NOVEL RP- HPLC METHOD FOR THE QUANTIFICATION OF CABOZANTINIB IN ACTIVE PHARMACEUTICAL INGREDIENTS AND PHARMACEUTICAL DOSAGE FORMSAbstract
A simple, specific, accurate reversed-phase high performance liquid chromatographic method was developed for the quantification of Cabozantinib. Although extensive studies on Cabozantinib have been developed for determining Cabozantinib in human place and urine by LC-MS, studies on the pharmaceutically active ingredient and formulation are scarce. The effective separation was achieved through BDS C18 150 × 4.6 mm, 5m using a mobile phase KH2PO4 Buffer and ACN (55:45% v/v). The flow rate of the mobile phase was 1.0 mL/min, and the detection was carried at a wavelength of 210 nm. The retention time of Cabozantinib was 2.932 nm. The correlation coefficient is 0.9998. The developed method was validated in terms of system suitability, specificity, linearity range, precision, accuracy, limits of detection and quantification. Degradation studies were performed on Cabozantinib to indicate the stability property and specificity of the proposed method. The information presented in this study will be useful for industrial application for determining Cabozantinib in active pharmaceutical ingredient and pharmaceutical dosage form.
A. K. Kuna *, G. Seru and G. V. Radha
Department of Pharmaceutical Analysis, Gitam Institute of Pharmacy, Gitam University (Deemed to be University), Rushikonda, Visakhapatnam, Andhra Pradesh, India.
27 November 2018
27 March 2019
29 March 2019
01 August 2019