A SIMPLE METHOD DEVELOPMENT, VALIDATION AND QUANTIFICATION OF LENVATINIB IN PHARMACEUTICAL DOSAGE FORM USING ZERO ORDER AND FIRST-ORDER DERIVATIVE NOVEL SPECTROPHOTOMETRIC METHODSAbstract
Simple, very Sensitive, rapid, and accurate novel spectro-photometric methods were developed to estimate Lenvatinib in Pharmaceutical dosage form using zero- and first-order derivative spectrophotometry. The solutions of Lenvatinib standard and sample were prepared using analytical grade methanol. The spectrophotometric estimation of lenvatinib was carried out at 240 nm in the zero-order method and 253 nm in the first-order derivative method. Developed methods were validated with respect to linearity, precision, accuracy, limit of detection and quantitation in accordance with International Council for Harmonisation (ICH) guidelines. Linearity was observed in the concentration range of 1-5 µg/mL for zero- and first-order derivative methods. LOD and LOQ of Lenvatinib were found to be 0.017 µg/mL and 0.052 µg/mL for zero-order and 0.165 µg/mL and 0.500 µg/mL for first-order derivative spectrophotometric methods, respectively. The %RSD values for inter-day and intra-day precision study were <2.0%. The method was linear, accurate and precise with recoveries in the range of 98 – 102 %, and minimum values of %RSD indicate the method’s accuracy. Developed spectrophotometric methods were successfully applied to assay Lenvatinib Capsule dosage form. The detailed quantitative results showed that this method is accurate, precise, and cost-effective and can be used for routine analysis of Lenvatinib in the capsule dosage form.