Simultaneous Estimation Of New Analytical Method Development And Validation Of Dabrafenib And Trametinib By High Performance Liquid Chromatography

Abstract

  An accurate, precise, simple, efficient and reproducible, isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Dabrafenib and Trametinib in bulk and combined pharmaceutical tablet dosage forms. Dabrafenib and Trametinib were separated by using a Symmetry ODS C18 (4.6mm×150mm) 5µm Particle Size; Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Methanol: 0.1% Orthophosphoric acid (64:36% v/v). The flow rate was set to 1ml/min with the responses measured at 224nm. The retention time of Dabrafenib and Trametinib was found to be 2.808min and 3.880min respectively with resolution of 5.68. Linearity was established for Dabrafenib and Trametinib in the range of 20-100µg/ml for Dabrafenib and 60-140µg/ml for Trametinib with correlation coefficient 0.999. The percentage recovery was found to be is 100.30% for Dabrafenib and 100.21% for Trametinib respectively. Validation parameters such as specificity, linearity, precision, accuracy and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantification of bulk and active pharmaceutical ingredient present and in combined tablet dosage form.