Abstract

Analytical Method Development and Validation for Tezacaftor and Ivacaftor in bulk and Combine Dosage Form by RP-HPLC, New method was established for simultaneous estimation of Tezacaftor and Ivacaftor by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tezacaftor and Ivacaftor by using Symmetry C18 5µm (4.6 x 150mm), flow rate was 1.0 ml/min, mobile phase ratio was Phosphate buffer (0.02M) pH-3.8: Methanol: Acetonitrile (60:20:20%v/v), detection wavelength was 260nm. The retention times of Tezacaftor and Ivacaftor were found to be 2.324mins and 4.314mins respectively. The % purity of Tezacaftor and Ivacaftor was found to be 99.865% and 99.658% respectively. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Tezacaftor and Ivacaftor was found in concentration range of 0µg-36µg and 0µg-39µg and correlation coefficient (r2) was found to be 0.9995 and 0.9998, % recovery was found to be 100.280, %RSD for repeatability was 0.174 and 0.709, % RSD for intermediate precision was 0.093 and 0.937 respectively. The precision study was precise, robust, and repeatable. LOD value was 1.377 and 1.079, and LOQ value was 4.174 and 3.272 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Tezacaftor and Ivacaftor in API and Pharmaceutical dosage form.