A STABILITY-INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SELINEXOR AND BORTEZOMIB IN BULK AND PHARMACEUTICAL DOSAGE FORM

Symmetric peak and effective peak resolution in chromatography were achieved by adjusting the mobile phase’s pH and amount of organic Phase. The retention time of 2.127 and 4.145 minutes was observed after the elution of Bortezomib and Selinexor respectively. To accurately measure both Selinexor and Bortezomib at the same time, an approach was developed with an optimal wavelength of 236nm. Selinexor and Bortezomib were successfully separated by chromatography using a mobile phase of Acetonitrile: 0.1% Formic acid (30:70, v/v) and Luna Phenyl Hexyl (250×4.6mm, 5μ) column running at 1.0 ml/min. When looking at the linearity range, statistics correlating 0.999 indicates a very excellent correlation. For intermediate precision intervals, the relative standard deviation of Selinexor and Bortezomib, respectively, was 0.47 and 0.53, indicating the reproducibility of the analytical approach. The suggested analytical approach has a low LOD, which means that it is also extremely sensitive. This indicates that the suggested approach has sample accuracy by ICH requirements, as 99.9 and 100.2 percent of the spiking Selinexor and Bortezomib, respectively, were recovered. According to ICH recommendations, forced degradation of under twenty per cent is acceptable. Selinexor and Bortezomib showed degradation of under 20 percent using the suggested approach, which indicates stability.