A novel rp-hplc method for the estimation of ivacaftor and tezacaftor in bulk and pharmaceutical dosage formulations
Keywords:Ivacaftor, Tezacaftor, RP-HPLC, Robustness and ICH Guidelines.
A selective and sensitive reverse phase high performance liquid chromatography (RP-HPLC) has been developed for the separation and quantification of and Ivacaftor and Tezacaftor in tablet dosage form and validated .The determination was carried out using Symmetry C18 column (250 mm ×4.6 mm id) as a stationary phase and mobile phase comprised of Methanol: TEA buffer pH 4.2 (40:60v/v) with pH adjusted to 4.2±0.5 by using Ortho phosphoric acid. The flow rate was 1.0ml/min and the eluent was monitored at 260 nm. The retention time of and Ivacaftor and r were 2.773 ±0.018 min and 4.065±0.024 min respectively. The Coefficient of correlation and percentage recoveries of Ivacaftor and Tezacaftor were 0.9986 and 100.0l % and 0.9994 and 99.98% respectively. The method is validated for accuracy, Precision, ruggedness and Robustness. The proposed method is successfully applied for the simultaneous determination of both drugs in commercial tablet preparation. The results of the analysis have been validated statistically and by recovery studies.