Validation, Quantification and Stress Degradation Studies of Lenvatinib Mesylate in Bulk Drug and Pharmaceutical Dosage Forms Using Ultra Performance Liquid Chromatography

Abstract

Objective: The objective of the present study was to develop a new method for the quantification of Lenvatinib mesylate in bulk drug and pharmaceutical dosage form using UPLC, to validate the developed method and to perform the stress degradation studies for the drug.

Method: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm x 2.1mm, 1.8m) column, mixture of 0.1% OPA and Acetonitrile (50:50) mobile phase run on an isocratic mode at a flow rate of 0.3ml/min, 240nm detection wavelength and column oven temperature maintained at 30ºC.

Results: The retention time for Lenvatinib was found to be 1.24min. The developed method was validated for various validation parameters in accordance to ICH guidelines. The method obeyed Beer’s law in the concentration range of 2.5µg/ml – 15µg/ml with correlation coefficient of 0.9996. The % RSD and % recovery was found to be 0.4 and 99.66% – 100.30% respectively. The method was found to be accurate, precise, specific, linear, rugged and robust. Forced degradation studies were conducted by exposing the drug to various stress conditions such as acidic, basic, peroxide, neutral, photolytic and thermal conditions. The net degradation was found within the limits.

Conclusion: The developed method for the estimation of Lenvatinib can be used for routine analysis in pharmaceutical dosage form.