Abstract

SIMULTANEOUS DETERMINATION OF LENVATINIB AND EVEROLIMUS BY HPTLC METHOD

*Ripple Parmar, Dr. Zarna Dedania and Dr. Vineet Jain

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Abstract

HPTLC Method was developed and validated for Lenvatinib (LEN), a tyrosine kinase inhibitor and mTOR inhibitor Everolimus (EVE) used to treat Renal cancer. Chromatographic separation of Lenvatinib and Everolimus in synthetic mixture was achieved on Silica gel aluminium plate 60F-254 (20 × 10 cm with 250 μm thickness) using mobile phase, Chloroform: Toluene: Methanol: Glacial Acetic Acid [4: 4: 2: 0.1 v/v/v/v]. Validation was performed at 254 nm wavelength. The calibration curve was found to be linear in the concentration range of 280 – 1400 and 100 – 500 ng/band for LEN and EVE, respectively. Well resolved bands were obtained with Rf value 0.8 for Lenvatinib and 0.25 for Everolimus with 99.74 and 99.72% recovery, respectively. The method is simple, rapid, accurate, precise, reproducible, and economic as per ICH guidelines and can be used for routine quantitative analysis of Lenvatinib and Everolimus combination.

Keywords: Lenvatinib, Everolimus, HPTLC, Anti-Cancer drugs.