METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF TRAMETINIB IN API FORM AND MARKETED TABLET DOSAGE FORM BY RP-HPLC

A. Myna*, M. Tandrima, A. Yasodha and K. Sujatha

ABSTRACT

A Simple, rapid, accurate, precise, robust and efficient and simple RP-HPLC method has been developed and validated for the determination of Trametinib in bulk and was applied on marketed Trametinib products. The mobile phase used for the chromatographic runs consisted of Acetonitrile and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70% v/v. The separation was achieved on a Symmetry C18 ODS (4.6mm × 250mm) 5μm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The method was linear at the concentration range 6–14 μg/ml for Trametinib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Trametinib limit of detection (LOD) and limit of quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively.

Keywords: Trametinib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.