Analytical Method Development and Validation for the Simultaneous Estimation of Tezacaftor and Ivacaftor by RP-HPLC Method

Chitraju Prathyusha, P. Sabiya*, B. Poornima
Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Tirupathi, A.P, India.

A B S T R A C T
The aim of present research work made to develop and validate simultaneous estimation of Tezacaftor and Ivacaftor was done by RP-HPLC. The optimized mobile phase was consists of Acetonitrile: Phosphate buffer pH 2.5 mixed in the ratio of 80:20 % v/ v. A Symmetry C18 (4.6 x 150mm, 5µ, Make XTerra) column used as stationary phase. The detection was carried out using UV detector at 274 nm. The flow rate was maintained at 0.8 ml/min. The linearity range of Tezacaftor and Ivacaftor were found to be from 25-125 µg/ml and the linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of Tezacaftor and Ivacaftor LOD and LOQ was found to be within limit. The proposed method is precise, simple and accurate to determine the amount of Tezacaftor and Ivacaftor in formulation. So the method can be useful in the routine quality control of these drugs.
Keywords: Symmetry C18 column, Tezacaftor and Ivacaftor, RP-HPLC, Stationary phase, Mobile phase