Development and validation of reversed-phase high-performance liquid chromatography method for the simultaneous determination of tezacaftor and ivacaftor in bulk and pharmaceutical formulation

Abstract

Objective: The objective of the study was to develop analytical method for the estimation of tezacaftor and ivacaftor
in bulk and its combination dosage form and to validate the method developed according to ICH guidelines.
Materials and Methods: Chromatographic separation was achieved through Ascentis C18 150 × 4.6 mm, 5 m
using 0.1% OPA: acetonitrile (70:30 v/v) mixture used as the mobile phase. The Water ACQUITY Model highperformance
liquid chromatography system with photodiode array detector and EMPOWER version 2.0 software
was monitored at detection wavelength 260 nm with flow rate of 1.0 ml/min and the method was validated as per
ICH guidelines. Results and Discussion: By applying the proposed method, the retention times of tezacaftor and
ivacaftor were found to be 3.0 and 3.6 min, respectively. %RSD of method precision for tezacaftor and ivacaftor
was found to be 0.8 and 0.5, respectively. % recovery was obtained as 99.61% and 99.92% for tezacaftor and
ivacaftor, respectively. Retention times were less so, the method developed was simple and economical and can be
adopted in regular quality control analysis for selected drugs. Conclusion: This method was successfully applied
for the determination of tezacaftor and ivacaftor in their pharmaceutical formulation and hence can be the routine
analysis of these drugs in combined dosage form.