Stability Indicating Rp- Hplc Method For Simultaneous Estimation Of Tezacaftor And Evacaftor In Tablet Dosage Form

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Ivacaftor and
Tezacaftor in Tablet dosage form. Chromatogram was run through Zodiacil C18 (150 x 4.6 mm, 3.5)
Mobile phase containing 0.01N KH2PO4: Acetonitrile taken in the ratio 55:45 was pumped through column
at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was
292.0 nm. Retention time of Ivacaftor and Tezacaftor were found to be 2.269 min and 3.164 min. %RSD
of the Ivacaftor and Tezacaftor were and found to be 0.5 and 1.0 respectively. %Recovery was obtained
as 100.14% and 100.07% for Ivacaftor and Tezacaftor respectively. LOD, LOQ values obtained from
regression equations of Ivacaftor and Tezacaftor were 0.56, 1.71 µg/ml and 0.07, 0.11 µg/ml respectively.
Regression equation of Ivacaftor is y = 14394x + 3350, and y = 6134.x + 432.1. of Tezacaftor. 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.