A new analytical method development and validation for estimation of rilpivirine and dolutegravir in bulk and tablet by RP-HPLC

Abstract

A New RP-HPLC Method for the Simultaneous Estimation of Dolutegravir and Rilpivirine in bulk and its Pure and Pharmaceutical Dosage Form as per ICH Guidelines. The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Dolutegravir and Rilpivirine in pure and combined dosage form. Chromatographic separation was done using Symmetry ODS C18 column having dimension of 4.6×250mm having particle size of 5.0µm, with mobile phase consisting of Acetonitrile: Methanol in the ratio 65:45v/v, flow rate was adjusted to 1ml/min and detection wavelength at 256nm. The retention times of Dolutegravir and Rilpivirine was found to be 2.256 and 5.427 mins. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Dolutegravir and Rilpivirine was found in range of 6µg-14µg and 18µg-42µg and correlation coefficient was found to be 0.999 and 0.999% RSD for intermediate precision was found to be 0.5 and 0.3, for repeatability was 0.4 and 0.1, % mean recovery for Dolutegravir and Rilpivirine was found to be 101.326% and 100.501% respectively. The method was found to be robust even by change in the mobile phase ±2% and in more and less flow conditions. The developed method can be successfully employed for the routine analysis of Dolutegravir and Rilpivirine in bulk and Pharmaceutical dosage forms.