Stability indicating validated method development for the simultaneous estimation of tezacaftor, ivacaftor & elexacaftor in API and pharmaceutical dosage form

Abstract

A Simple accurate, precise method was developed for the simultaneous estimation of the Tezacaftor, Ivacaftor and Elexacaftor in bulk and tablet dosage form. Chromatogram was run through Kromasil C18 150×4.6 mm, 5µ. Mobile phase containing 0.1% OPA and acetonitrile in the ratio of 60: 40 v/v was pumped through column at a flow rate of 1ml / min. Temperature was maintained at 30º c. Optimized wavelength for Tezacaftor, Ivacaftor and Elexacaftor was 260.0 nm. Retention time of Tezacaftor, Ivacaftor and Elexacaftor were found to be 3.468 min, 2.322 min and 2.855 min. % RSD of system precision for Tezacaftor, Ivacaftor and Elexacaftor were found to be 1.0, 0.6 and 1.4 respectively. % RSD of method precision for Tezacaftor, Ivacaftor and Elexacaftor were found to be 1.0, 0.4 and 1.2 respectively. % Recovery was obtained as 99.44%, 100.03% and 100.15% for Tezacaftor, Ivacaftor and Elexacaftor respectively. LOD, LOQ values obtained from regression equations of Tezacaftor, Ivacaftor and Elexacaftor were 0.07 ppm and 0.21ppm, 0.29 ppm and 0.88 ppm ,0.40 ppm and 1.20 ppm respectively. Regression equation of Tezacaftor was y=10491x + 863.8, Ivacaftor was y= 18876x + 7683 and Elexacaftor was y= 33896x + 19526. Retention times are decreased, so; the method developed was simple and economical that can be adopted in regular Quality control test in Industries.