Abstract

NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF IVACAFTOR AND TEZACAFTOR IN SOLID DOSAGE FORM

Laxmi Prasanna M.*, Anjali Bakshi and Dr. Bhagavan Raju M.

Abstract

A stability indicating RP-HPLC method was developed and validated for the determination of Ivacaftor and Tezacaftor in bulk and tablet dosage form. This method was carried out using Dionex, C18 (4.6 x KH2PO4: Methanol (60:40) under isocratic mode with an injection volume 10μl and at flow rate of 1ml/min and both the analytes were monitored at 232nm. Stress conditions were performed by subjecting the individual analytes to the hydrolysis (acid, base), oxidation, thermal, photolytic and neutral stress conditions. The retention times of Ivacaftor and Tezacaftor were 2.397 and 3.296 minutes respectively and showed a good linearity in the concentration range of 75-225 μg/ml for Ivacaftor and 50-150 μg/ml for Tezacaftor with a correlation coefficient of 0.9997 and 0.9993. The % recoveries of Ivacaftor and Tezacaftor found to be 99.28% and 100.15% respectively. The analytical performance of the proposed method was validated for specificity, linearity, accuracy, precision, robustness, LOD and LOQ. The method was validated as per ICH guidelines. The proposed method can be used for routine estimation of Ivacaftor and Tezacaftor in pharmaceutical dosage form.

Keywords: Ivacaftor, Tezacaftor, RP?HPLC, Simultaneous estimation, stability indicating, method validation.