Analytical RP-HPLC Method Development and Validation for the Estimation of Lenvatinib and API Form and Marketed Pharmaceutical Dosage Forms
Abstract
An Analytical, Precise, accurate, robust and efficient and simple RP-HPLC method has been developed and validated for the determination of Lenvatinib in bulk and was applied on marketed pharmaceutical dosage form. The mobile phase used for the chromatographic runs consisted of Methanol and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30: 70% v/v. The separation was achieved on a Kromasil C18 ODS (4.6mm × 250mm) 5µm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The retention time for Lenvatinib was found to be 5.404minutes. The developed method was linear at the concentration range 6–14 μg/ml for Lenvatinib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Lenvatinib limit of detection (LOD) and limit of quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively.
How to Cite This Article
Dr. CH Kantlam, P Amani, Kavya, Sowjanya, Poojitha, Shruthika, Harshitha (2025). Analytical RP-HPLC Method Development and Validation for the Estimation of Lenvatinib and API Form and Marketed Pharmaceutical Dosage Forms . International Journal of Pharma Growth Research Review (IJPGARR), 2(4), 01-08.