Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Objective: The present study is to develop a highly suitable simple, specific, rapid and validated stability-indicating reverse-phase high performance liquid chromatography method for the estimation of tepotinib in bulk and pharmaceutical formulation as per ICH guidelines. Method: The chromatographic separation of components was achieved on a Phenomenox Kinetex XB-C18(150×4.6 mm, 5μ) column. The flo rate as . ml min and the absorbance were noted at 272 nm. The procedures and abilities of the method were evaluated against the criteria for linearity, precision, accuracy, system suitability, specificity, and robustness according to the ICH guidelines. Results: The retention time for Tepotinib was 3.4 min. The calibration plot was linear in the range 5-25μg/ml and (r2= .9993) and the % mean recoveries for accuracy and precision of tepotinib were in the range (%Relative Standard Deviation˂ 2). The Limit of Detection and Limit of Quantification were determined to be 0.429 μg/ml and 1.3 μg/ml respectively.