A New Stability-Indicating RP-UPLC Method Development and Validation for the Simultaneous Estimation of Ivacaftor and Tezacaftor in Pharmaceutical Dosage Form

Author(s): B Balaswami* and P. Venkata Ramana

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 CHS C18 (100 x 2.1 mm, 1.7) and the mobile phase containing water: acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 0.3 ml/min. The temperature was maintained at 30 °C throughout the method. Optimized wavelength selected was 292.0 nm. Retention time of Ivacaftor and Tezacaftor were found to be 0.620 min and 1.155 min. %RSD of the Ivacaftor and Tezacaftor were and found to be 0.5 and 0.5 respectively. %Recovery was obtained as 99.52% and 100.61% for Ivacaftor and Tezacaftor respectively. LOD, LOQ values obtained from regression equations of Ivacaftor and Tezacaftor were 0.30, 0.10 μg/ml and 0.91, 0.31 μg/ml respectively. Regression equation of Ivacaftor is y = 5052.x + 958.8, and y = 5012.x + 245.4 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.

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