The main objective of the study was to develop a simple, specific and reliable method for quantification of ivacaftor and its impurities in samples by high performance liquid chromatography. The separation of these compounds was achieved on a C18 column using a gradient mobile phase consisting of phosphoric acid and acetonitrile. The analysis was performed at a flow rate of 1.0 ml/min and detection wavelength of 220 nm. The specificity, linearity, sensitivity, accuracy, precision and robustness were examined as part of method validation. Forced degradation showed that ivacaftor does not undergo degradation under heat, oxidation and photolysis but that it was susceptible to acidic and basic conditions.
Loading....