DEVELOPMENT AND VALIDATION OF NOVEL UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TEPOTINIB IN BULK AND IN PHARMACEUTICAL FORMULATION
Keywords:Tepotinib, UV spectrophotometer, Methanol, Validation, International council for Harmonization guidelines
Objective: The objective of the study is to develop a new, simple, rapid, accurate, and economical UV-spectrophotometric method and validate the same for the estimation of Tepotinib in bulk and in pharmaceutical formulation as per ICH guidelines.
Methods: The present work was carried out using the UV-Visible double-beam spectrophotometer model Systronics 2201. Tepotinib was found soluble in water, methanol, methanol so, analytical-grade methanol was used as a solvent for conducting the work. The λmax of the tepotinib was determined by dissolving pure drug in methanol scanned in the range of 200-800 nm. The present method was validated for the linearity, accuracy, precision, Limit of Detection and Limit of Quantification.
Results: The maximum absorbance of tepotinib obtained at a wavelength of 272 nm. The method was found linear in the range of 3-15 µg/ml with the regression coefficient of 0.996 and the equation y = 0.0699x+0.0335. The accuracy was found to be in the range of 96.8-98.5%, the intra-day and inter-day precision % RSD value was 0.262 and 0.69, respectively and the LOD and LOQ were 0.0925 µg/ml and 0.28 µg/ml respectively.
Conclusion: The method demonstrated good reproducibility and recovery so, proposed method can be successfully applied for the routine analysis of tepotinib in bulk and pharmaceutical dosage form.
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