Abstract

Gangu Sreelatha*, N. Sai Lokesh, K. Srivaishnavi, Kiran Rapolu and Tadikonda Rama Rao

ABSTRACT

A new simple, selective, rapid, precise reversed phase high performance liquid chromatography method has been developed and validated for the estimation of Tepotinib in bulk and its pharmaceutical dosage form. The separation was made using Symmetry ODS C18 (4.6×150mm, 5μm) column. Mobile phase used contained Methanol: Phosphate Buffer pH-4.2 adjusted with orthophosphoric acid solution in the ratio of 35:65% v/v in isocratic mode at wavelength of 236nm. The mobile-phase flow rate and the sample volume injected were 1 ml/min and 10 μl, respectively. Retention time of Tepotinib was found to be 2.8 ±0.2mins. A good linear relationship Tepotinib r2=0.999) was observed over a concentration range of 20 to 100μg/ml of Tepotinib. The limit of detection (LOD) and limit of quantification (LOQ) for Tepotinib was found to be 2.6 μg/ml and 6.35μg/ml. % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%. The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Tepotinib in bulk and marketed pharmaceutical dosage form dosage form. It was concluded that in the present developed RP- HPLC method is simple, rapid, and accurate, hence can be used for routine quality control analysis in pharmaceutical industry. During force degradation, drug product was exposed to hydrolysis (acid and base hydrolysis), H2O2, thermal degradation and photo degradation. The % degradation was found to be 10 to 20% for both Tepotinib in the given condition. The method specifically estimates both the drugs in presence of all the degradants generated during forced degradation study. The developed methods were simple, specific and economic, which can be used for simultaneous estimation of Tepotinib in tablet dosage form.