STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CABOZANTINIB IN PHARMACEUTICAL DOSAGE FORMS BY ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHY

Gorja Ashok; Sumanta Mondal

doi:10.22159/ajpcr.2018.v11i10.27409

Authors

Gorja Ashok Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Gland Institute of Pharmaceutical Sciences, Kothapet, Medak, Telangana, India.
Sumanta Mondal Department of Pharmaceutical Chemistry, Faculty of Pharmacy, GITAM Institute of Pharmacy GITAM University, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i10.27409

Keywords:

Cabozantinib, Stability indicating, Method development, Validation, Ultra-performance liquid chromatography

Abstract

Objective: The proposed study aimed to develop a stability-indicating ultra-performance liquid chromatography (UPLC) method for the estimation of cabozantinib in pharmaceutical dosage form and validate the method in accordance with the International Conference on Harmonization guidelines.

Methods: The optimized conditions for the developed UPLC method are Acquity UPLC Hibar C18 (100 mm Ã— 2.1 mm, 1.7 Î¼) column maintained at 30Â°C with mobile phase consisting of 0.1% orthophosphoric acid and acetonitrile in the ratio of 55:45% v/v on isocratic mode at flow rate of 0.3 mL/ min. The sample was detected at 244 nm.

Results: The retention time for cabozantinib was deemed 1.3 min. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness, and solution stability. The method obeyed Beer's law in the concentration range of 20 Î¼g/mL and 120 Î¼g/mL with correlation coefficient of 0.9997. Forced degradation studies were conducted by exposing the drug solution to numerous stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was considered within the limits, indicating that drug is stable in stressed conditions.

Conclusion: The developed method for the estimation of cabozantinib can be utilized for the routine analysis of pharmaceutical dosage form.

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