RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TEPOTINIB IN PRESENCE OF ITS IMPURITIES IN A TABLET DOSAGE FORM

A simple, rapid, precise, sensitive and reproducible Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Tepotinib in presence of its impurities (1&2) in pharmaceutical dosage form. Chromatographic separation of Tepotinib and its known impurities were achieved on Waters Allianace-e 2695 by using Inertsil ODS C18 250×4.6mm 5µ column and the mobile phase containing (0.01M) KH₂PO₄ PH-2.5&Acetonitrile in the ratio of 50:50% v/v. The flow rate was 1.0ml/min; detection was carried at 263nm using a photodiode array detector at ambient temperature. The calibration range was 10-60µg/ml for Tepotinib, 2.5-15µg/ml for Imp-1& 3.75-22.5µg/ml for Imp-2. %Relative standard deviation of peak areas of all the measurements less than 2%. Recovery was obtained between 98-102%. Stability studies were also performed with known impurities the drug showed maximum degradation in alkaline stress condition. The proposed method was validated according to ICH guidelines. The results obtained were within the acceptable limits. The proposed method was found to be simple, economical, precise, accurate & robust for quantitative analysis of Tepotinib in presence of its impurities.