Stability Indicating UPLC Method Development and Validation of Lenvatinib

Author(s): Sai Prasanna A*, Meruva Sathish Kumar, R. V. Valli Kumari and S. Marakatham

Abstract: A new precise accurate, rapid method has been developed for the estimation of lenvatinib pharmaceutical dosage form by UPLC. From results the proposed method if highly sensitive, précised and accurate and it successfully applied for the quantification of API content in commercial formulations of Lenvatinib Educational Institutions and Quality Control Laboratories. A simple and selective UPLC method is described for the determination of lenvatinib & Chromatographic separation was achieved on a Acquity BEH C18 (50*3.00mm. 1.7μm) using mobile phase consisting of 0.1% ortho-phosphoric acid: Acetonitrile (60:40) v/v was pumped with flow rate of 0.5ml/min with isocratic elution mode and optimised wavelength was 248nm. Linearity was observed in the range 30-70μg/ml for lenvatinib (r2 =0.994). Accuracy was also performed at 50, 100, 150% recovery and the result obtained was 100.8 and it is within the range 98-102%. Robustness was performed with 2 different parameters by changing the flow rate and temperature and tailing factor obtained was within the limits. Different degradation studies like peroxide degradation, photolytic degradation, Acid degradation, Alkaline degradation, Thermal degradation studies were performed. Validation parameters performed were in good agreement with the acceptance limits.

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