Development and Validation of rp-HPLC Method of Cabozantinib in Active Pharmaceutical Ingredient and Pharmaceutical Dosage form

A specific, accurate rp-HPLC (reversed-phase high performance liquid chromatographic) method was developed for the quantification of Cabozantinib. The effective separation was achieved through reversed-phased C18 column 4.6 x 250 mm, 5 mu m using a mobile phase Methanol: phosphate buffer (ph. 3.00) with orthophosphoric acid (OPA) (55:45 % v/v). The flow rate of the mobile phase was found to be 0.8 mL/min. The detection was carried at a wavelength of 244 nm. The retention time of Cabozantinib was found to be 3.702 min. The correlation coefficient was found to be 0.9999. The developed method was accurately validated in the terms of accuracy, linearity range, precision, system suitability, robustness, limit of detection and limit of quantification. The details presented in this test will be useful for industrial application for determining Cabozantinib in active pharmaceutical ingredient and pharmaceutical dosage form.

Automated summary

A specific and accurate rp-HPLC method was developed for quantification of Cabozantinib, utilizing a C18 column and specific mobile phase for effective separation. The method was validated for accuracy, linearity range, and precision, suitable for industrial applications in determining Cabozantinib.