Method Development and Validation of Simultaneous Estimation of Tezacaftor and Ivacaftor in Api by Rp-Hplc

Abstract

An economic, uncomplicated, selective, detailed, and accurate RP-HPLC procedure for simultaneous quantitative determination of tezacaftor and ivacaftor in combined dosage forms, was formulated and validated according to ICH guidelines. The method was developed using Agilent 1200 series HPLC and Hypersil BDS (150x4.6mm ID) 5.0µm column in isocratic mode, with mobile phase comprising of mixed phosphate buffer: acetonitrile (70:30) the flow rate was 1.0 ml/min and the detection was carried at a wavelength of 274nm. The retention time and percentage assay of purity for tezacaftor and ivacaftor was found to be 3.386 min and 4.433
min, 99.5% and 99.9% respectively. The method was successfully validated for accuracy, precision, ruggedness, linearity and range, specificity and robustness in accordance with ICH guidelines. The proposed method was found to be within the acceptance limits indicating that the method is accurate, specific and economical