Stability-Indicating High Performance Liquid ...

Stability-Indicating High Performance Liquid Chromatographic Method for the Assay of Lenacapavir in Bulk and Formulated Dosage Forms

Author Name : Kethavath Avinash, Dr. Raviteja Bandla

ABSTRACT Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. It helps in establishment of product-specific acceptance criteria and stability of results. In view of this the present work is intended to develop an efficient and simple HPLC method for the determination of Lenacapavir in bulk and was applied on marketed Lenacapavir products. The pharmaceutical drug containing Lenacapavir is in combination with other antiretrovirals, is indicated for the treatment of HIV/AIDS. It is used in heavily treatment-experienced adults with multiple drug resistance in whom current antiretroviral therapy is ineffective due to resistance, intolerance or safety considerations. In HPLC method mobile phase used for the chromatographic runs consisted of Methanol: water: 0.1 % sodium dihydrogen orthophosphate in 60:30:10 (v/v).