Abstract

The present work aimed to develop a new simple, accurate and reproducible RP-HPLC method for the analysis of Selinexor in bulk and tablets. The HPLC analysis was performed on the Phenomenex Gemini C18 (250 mm × 4.60 mm), 5µm particle size in isocratic mode, at 25 0C temperature using a mobile phase consisting of methanol: water (95:5, v/v) at a flow rate of 1.0 mL/min. The detection was carried out at 254 nm. There was no interference from the excipients commonly present in the tablets. The drug content was found to be 99.933 % for SLN. Accuracy of the method was studied by the recovery studies at three different levels 80 %, 100 % and 120 % level. The % recovery was found to be within the limits of the acceptance criteria with average recovery of 99.37-99.98. The % RSD below 2.0 shows the high precision of proposed method. Results of precision studies carried out intraday and interday by using different concentrations of SLN 6, 8 and 10 µg/mL and showed %RSD in range of 0.47-1.36 and 0.64-0.99 respectively. Therefore, the results confirmed the suitability of the method for quantifying Selinexor in their formulations.

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