Asian Journal of Pharmaceutical Research

  • Year: 2019
  • Volume: 9
  • Issue: 4

Development and Validation of UPLC method for the determination of Lenvatinib in Capsule formulation

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

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.

Keywords

Lenvatinib, development, validation, ICH guidelines, UPLC method