Abstract

A novel and effective reversed-phase high-performance liquid chromatographic (RP-HPLC) technique has been developed to determine the tepotinib, an anti-cancer drug, in a tablet formulation. Furthermore, this method has been validated in accordance with the guidelines of the International Conference on Harmonization. The mobile phase consisted of a mixture of potassium dihydrogen orthophosphate and acetonitrile in a ratio of 15:85 v/v, while the flow rate of the mobile phase was maintained at a constant rate of 1.0 ml/minute. The analysis was conducted using an isocratic approach on a C18 analytical column with dimensions of 250 × 4.4 mm and a particle size of 5 μm. To detect tepotinib, a photo diode array detector was employed, with a wavelength of 284 nm. The quantification of tepotinib was not affected by the presence of excipients. The concentration range of the calibration curve was linear, spanning from 8 to 12 μg/ml. In terms of precision, both intra-day and inter-day relative standard deviations were found to be less than 2%, thus indicating high precision and repeatability. The recovery rate of the compound ranged from 99.76%–101.34 %, with relative standard deviations not exceeding 2%. The limit of detection and quantification were determined to be 0.02 μg/ml and 0.06 μg/ml, respectively. The system suitability parameters were deemed to be within the acceptable range. Therefore, this current report proposes an innovative analytical approach for the evaluation of a recently discovered anti-cancer drug, tepotinib, through the utilization of the RP-HPLC methodology.

Key words: Tepotinib, high performance liquid chromatography method, validation, tablet dosage form, market sample analysis.