NOVEL METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC OF TEZACAFTOR, IVACAFTOR IN HUMAN PLASMA

A simple, precised, accurate method was developed for the estimation of Tezacaftor, Ivacaftorin human plasma using the Stavudine as internal standard by RP-HPLC (Reverse phase-High performance Liquid Chromatographic) technique. Chromatographic conditions used are stationary phase Kromasil c18 (250 x 4.6 mm x 5 mu m), Mobile phase 0.01N Di Sodium hydrogen phosphate (pH: 3.0): Acetonitrile in the ratio of 65:35(v/v) and flow rate was maintained at 1.0ml/min, detection wave length was 255nm, column temperature was set to 30 degrees C and Diluent used is water: Acetonitrile (50:50). Conditions were finalized as optimized Conditions. Retention time of Ivacaftor and Tezacaftor were found to be 4.83min and 7.88min. %CV of the Tezacaftor and Ivacaftor were found to be 0.19% and 1.14%. % Recovery was obtained as 99.19% and 96.91%. The linearity concentration is in the range of 0.3-12 mu g/mL of Tezacaftor, 0.062.4 mu g/mL of Ivacaftor. The lower limits of quantification were 0.3 mu g/mL of Tezacaftor and 0.06 mu g/mL of Ivacaftor which reach the level of both drugs possibly found in human plasma.