Abstract

MOST RELIABLE, SPECIFICA AND VALIDATED METHOD OF LENVATINIB MESYLATEFOR ITS RELATED COMPOUNDS INCLUDING PROCESS IMPURITIES

Yashraj Majmudar*, Dharmesh Shah, Chandrasekhar Lohani, Dr. Rajendra Chavda, Kishan Patel, Tushar Tailor, Bhavesh Solanki

ABSTRACT

A rapid, fast, accurate, and precise method was developed and validated for the estimation of related substances in Lenvatinib mesylate using reverse-phase high-performance liquid chromatography (RP-HPLC). The separation was carried out by using Inertsil ODS-3V (250 × 4.6 mm, 5 μm) analytical column, column temperature was maintained at 30°C for better separation and resolution, the detection was carried out on 250nm wavelength with flow rate of 1.0mL/minute. The analysis was performed on a gradient 0.01 M ammonium acetate (pH adjusted to 4.20 with acetic acid) used as mobile phase A and a mixture of buffer and methanol in the ratio of 30:70%v/v as mobile phase B. Linearity was established for impurities in the range of 0.12-0.90μg/mL with correlation coefficient (r2) greater than 0.99. Accuracies were achieved between 80% to 120%. Validation parameters such as specificity, linearity, accuracy, precision, limit of quantification, limit of detection are performed according to the ICH guidelines. This method can be applied for the estimation and analysis of related substances in Lenvatinib mesylate.

Keywords: Lenvatinib mesylate, Lenvima, Related substances, Method development, Method validation.