Development and validation of an RP-HPLC method for the quantification of impurities of icatibant injection in finished formulations-identification and characterization of its impurities via LC-HRMS.
In the present study, an efficient reverse-phase high-performance liquid chromatography method was developed for the quantification of impurities of icatibant (IBT) injection in finished formulations. The stationary phase employed is Kromasil 100 C18 with dimension of (150 × 4.6) mm, 3.5 µm. A 0.05 M KH2PO4 (pH 2.5) an...