A Novel Stability Indicating RP-HPLC Analytical Method Development and Validation for the Determination of Tepotinib in Bulk and Pharmaceutical Dosage Form

Reverse phase isocratic liquid chromatography (RP-HPLC) is a technique that is simple, specific, exact, and sensitive. The main objective of this research work is to develop and validate RP-HPLC and then perform stability studies on Pharmakon and formulations for the evaluation of Tepotinib. Successful chromatographic elution of Tepotinib was achieved on column Kromosil C18, (4.6 x 150) mm, 5µm, with a movable phase comprises of 1% Orthophosphoric acid: Acetonitrile (70:30 v/v). The detecting wavelength for Tepotinib evaluation was preferred at 308nm with run time at 1.0ml/min and volume of injection is 10µl. Tepotinib linearity was attained with a correlation coefficient of 0.999 at concentration between 5.625-33.75µg/ml. The elution time for Tepotinib was found to be 2.492 minutes using a 5mins run time. According to ICH criteria, the developed method has been validated for a numerous analytical parameter like specificity, linearity, limit of detection (LOD) and limit of quantification (LOQ), precision, accuracy and robustness. The validation’s results showed outstanding agreement with the permitted range. The experiment’s outcomes proved that the proposed technology is appropriate for routine evaluation and quality control of pharmaceutical formulations that contain active drugs.