Development and Validation of UPLC method for the determination of Lenvatinib in Capsule formulation Srinivas Akula1, Mahtab Tayyaba2, Tabasum Sayeeda2, Abrar3, Jyothi K.4 1Department of Pharmacology, St. Mary's College of Pharmacy, St. Francis Street, Secunderabad, Telangana, India-500025 2Department of Quality Assurance, Bhaskar Pharmacy College, Yenkapally, Moinabad, Telangana, India-500075 3Department of Quality Assurance, St. Mary's College of Pharmacy, St. Francis Street, Secunderabad, Telangana, India-500025 4Department of Pharmaceutical Chemistry, St. Mary's College of Pharmacy, St. Francis Street, Secunderabad, Telangana, India-500025 *Corresponding Author E-mail: akulasrinivas305@gmail.com
Online published on 31 December, 2019. Abstract A new, simple and selective method was developed to estimate Lenvatinib pharmaceutical dosage form by UPLC. Ideal Chromatographic peak of separation was attained on a Acquity BEH C18 (50*3.0mm. 1.7μm) using mobile phase consisting 0.1% Orthophosphoric acid: ACN (60: 40) v/v with detection of 248 nm. Linearity of the drug was observed in the concentration range 60–140 μg/ml (r2 =0.994). From the results, the developed method was simple, sensitive, precise and accurate and it can successfully be applied for the determination of API in the commercial formulations of Lenvatinib in quality control laboratories. Top Keywords Lenvatinib, development, validation, ICH guidelines, UPLC method. Top |