Method development and validation for simultaneous estimation of rilpivirine and doultegravir by using RP – HPLC method in bulk dosage form
Keywords:
Rilpivirine, HPLC, ICH GuidelinesAbstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run through Agilent C18 (4.6 x 150mm, 5µm) Mobile phase containing Buffer 50% OPA: 50% Acetonitrile was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 257 nm. Retention time of Dolutegravir and Rilpivirine were found to be 2.399 min and 2.853 min. %RSD of the Dolutegravir and Rilpivirine were and found to be 0.8 and 1.6 respectively. %Recovery was obtained as 99.06% and 100.16% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values obtained from regression equations of Dolutegravir and Rilpivirine were 1.08, 3.26 and 0.56, 1.69 respectively. Regression equation of Dolutegravir is y = 11916x + 4431., and y =208758x + 2773. of Rilpivirine. 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.
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