RP-HPLC method development and validation for the simultaneous determination of elexacaftor, ivacator and tezacaftor in pharmaceutical dosage forms

https://doi.org/10.54037/WJPS.2022.101002

Abstract

A simple, accurate, precise method was developed for the simultaneous estimation of the Ivacaftor, Elexacaftor and Tezacaftor in bulk and tablet dosage form. Chromatogram was run through Ascentis C18 150 x 4.6 mm, 2.4m. Mobile phase containing acetonitrile & NH2PO4  in the ratio of 60:40 v/v was pumped through column at a flow rate of 1ml/min. Temperature was maintained at 30°C. Optimized wavelength for Ivacaftor, Elexacaftor and Tezacaftor  was 258.0 nm. Retention time of Ivacaftor, Elexacaftor and Tezacaftor were found to be 2.798 min, 2.137 min and 3.284 min %RSD of system precision for Ivacaftor, Elexacaftor and Tezacaftor were and found to be 0.4, 0.3 and 0.5 respectively. %RSD of method precision for Ivacaftor, Elexacaftor and Tezacaftor were and found to be 0.6,0.3, and 0.5 respectively. % recovery was obtained as 99.93%, 100.07% and 100.17% for Ivacaftor, Elexacaftor and Tezacaftor respectively. LOD, LOQ values are obtained from regression equations of Ivacaftor, Elexacaftor and Tezacaftor were 0.07 ppm, 0.09 ppm, 0.02 ppm and 0.22 ppm, 0.28 ppm, 0.7 ppm respectively. Regression equation of Tezacaftor was y = 23377x + 200.3, Ivacaftor was y = 17233x + 3180 and of Elexacaftor was y = 25892x + 1146. Retention times are decreased so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.