Abstract

METHOD DEVELOPMENT AND METHOD VALIDATION FOR ESTIMATION OF RILPIVIRINE AND CABOTEGRAVIR BY USING RP-HPLC METHOD

Revathi B.*, Ganesh A., Farhath Fathima B., Manasa K., Sushma D. and Sarika B.

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Rilpivirine and Cabotegravir in Tablet dosage form. Chromatogram was run through Ascentis (4.6x 150mm, 3.8μm). Mobile phase containing Buffer 0.01N K2HPO4. Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 1.1 ml/min. Buffer used in this method was 0.01N K2HPO4 buffer. Temperature was maintained at 30ºC. Optimized wavelength selected was 252 nm. Retention time of Rilpivirine and Cabotegravir were found to be 2.169min and 2.746 min. %RSD of the Rilpivirine and Cabotegravir were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 99.58% and 99.84% for Rilpivirine and Cabotegravir respectively. LOD, LOQ values obtained from regression equations of Rilpivirine and Cabotegravir were 0.07, 0.21 and 0.04 0.12 respectively. Regression equation of Rilpivirine is y = 18241x + 1968.1, and of y = 11344x + 847.95 Cabotegravir. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Cabotegravir, HPLC, Method Development, Method Validation, Rilpivirine, Simultaneous Estimation Method, Stability studies.