RP-HPLC Method Development and Validation for Estimation of Lenvatinib In Bulk and Pharmaceutical Dosage Form

The objective of present work was to develop and validate a rapid reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantitative analysis of lenvatinib in bulk and pharmaceutical dosage forms. Chromatographic analyses were performed on an ODC column of 250mm 4.6mm: i.d and 5µ particle size with a mobile phase comprising of 0.5M ammonium acetate and acetonitrile in the ratio 90:10 v/v. The   flow rate maintained at 1 ml/min, detected lenvatinib at RT 1.15 minutes. The lenvatinib was detected and quantitated using a photodiode array detector at a wavelength of 367 nm. The method was shown to be specific and linear in the range of 20-120?g/ml (r2= 0.999). The precision (intra- and inter-day) was demonstrated. The method is robust relative to changes in flow rate, column and temperature. The limits of detection and quantitation were 0.4 and 0.12µg/ml respectively. Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The method fulfilled the requirements for reliability and feasibility for application to the quantitative analysis of lenvatinib in bulk and pharmaceutical dosage forms.