Development and Validation of Tezacaftor and Ivacaftor in combined Pharmaceutical Dosage form by RP- UPLC

A simple, sensitive, precise, reportable and less time-consuming method was developed for Tezacaftor and Ivacaftor using a reverse phase UPLC system. Chromatographic separation was achieved by isocratic elution on a Water Acquity UPLC CHS C-18, 50x2.1mm, 1.8µm column. The mobile phase used was 0.1% OPA (pH 2.2) and Acetonitrile in a ratio of 60:40% v/v. The flow rate was found to be 0.3mL min -1 and the detection wavelength was 292nm. The retention times of tezacaftor and ivacaftor were found to be 0.508 and 0.876 min, respectively. The % recovery was found to be between 98-102% indicating accuracy of the method. The % assay was found to be 100.10% indicating the quality and purity of the drug. The detection limits for tezacaftor and ivacaftor were found to be 0.12 and 0.27 μg mL-1, respectively. The limit of quantification (LOQ) for tezacaftor and ivacaftor was found to be 0.37 and 0.81 μg mL-1, respectively. This method has been validated according to ICH guidelines and can be used to evaluate drug purity in bulk and dosage forms