METHOD DEVELOPMENT AND VALIDATION OF IVACAFTOR AND TEZACAFTOR BY RP-HPLC METHOD

Abstract

A simple, accurate, and precise RP-HPLC method was developed for the simultaneous estimation of Ivacaftor and Tezacaftor in tablet dosage form. The chromatographic separation was achieved using a Zodiacil C18 (150 × 4.6 mm, 3.5 µm) column with a mobile phase consisting of 0.01N KH₂PO₄: Acetonitrile (55:45, v/v) at a flow rate of 1.0 mL/min. The column temperature was maintained at 30°C with UV detection at 292.0 nm. The retention times for Ivacaftor and Tezacaftor were 2.269 min and 3.164 min, respectively. The method exhibited excellent precision with %RSD values of 0.5% and 1.0% for Ivacaftor and Tezacaftor, respectively. Recovery studies yielded 100.14% and 100.07% for Ivacaftor and Tezacaftor, respectively. Limits of detection (LOD) and quantification (LOQ) were 0.56 and 1.71 µg/mL for Ivacaftor, and 0.07 and 0.11 µg/mL for Tezacaftor, respectively. Linear regression equations were y = 14394x + 3350 for Ivacaftor and y = 6134x + 432.1 for Tezacaftor with excellent correlation coefficients exceeding 0.999. The developed method was validated according to ICH Q2(R2) guidelines and demonstrated to be simple, economical, and suitable for routine quality control testing in pharmaceutical industries.