Method development and validation for the quantitative estimation of Trametinib in API form and marketed tablet dosage form by RP-HPLC

Abstract

The development of analytical methods is in need for the estimation of Trametinib in pure and different pharmaceutical formulations. A simple, sensitive, rapid, accurate, precise and economic chromatographic method was developed and validated for Trametinib in pure and pharmaceutical formulations. The proposed method was validated according to the International Conference on Harmonization (ICH) guidelines. This separation is performed on Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm Column and mobile phase consists of ACN : Methanol: 0.1% OPA in the ratio of 60:30:10v/v/v at flow rate of 1.0ml/min. The wave length (λmax) used for the estimation of Trametinib is 267 nm by chromatographic method. The linearity of the calibration curve was validated by the high values of the correlation coefficient of regression. The percentage of Trametinib recovered was found to be within the limits i.e. 98-102% for Trametinib. LOD and LOQ values for Trametinib were found to be 0.08µg/ml and 0.24µg/ml respectively. The developed methods are simple and suitable for the determination of Trametinib in pure and pharmaceutical preparations.