Abstract

SIMULTANEOUS ESTIMATION OF LATEST ANALYTICAL METHOD IMPROVEMENT AND VALIDATION OF DABRAFENIB AND TRAMETINIB BY MEANS OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Santhosh Illendula* and G. Mariya Therisa

ABSTRACT

A correct, particular, easy, inexperienced and reproducible, isocratic Reversed section-high overall performance Liquid Chromatography (RP-HPLC) technique became developed and established for the simultaneous estimation of Dabrafenib and Trametinib in bulk and mixed pharmaceutical pill dosage paperwork. Dabrafenib and Trametinib were separated through the usage of a Symmetry ODS C18 (4.6mm×150mm) 5μm Particle length; Waters Alliance e2695 HPLC device with 2998 PDA detector and the cellular phase contained a combination of Methanol: zero.1% Orthophosphoric acid (64:36% v/v). The float price has become set to 1ml/min with the responses measured at 224nm. The retention time of Dabrafenib and Trametinib changed into discovered to be 2.808min and three.880min respectively with resolution of 5. sixty-eight. Linearity emerge as installation for Dabrafenib and Trametinib in the shape of 20-a hundred μg/ml for Dabrafenib and 60-one hundred forty μ g/ml for Trametinib with correlation coefficient 0.999. The percentage healing emerges as decided to be is a hundred.30% for Dabrafenib and a hundred.21% for Trametinib respectively. Validation parameters alongside specificity, linearity, precision, accuracy and robustness, restriction of detection (LOD) and restrict of quantitation (LOQ) were evaluated for the technique everyday with the worldwide conference on Harmonization (ICH) Q2 R1 guidelines. The superior method has end up effectively completed for the quantification of bulk and active pharmaceutical thing present and in blended pill dosage form.

Keywords: Dabrafenib and Trametinib, RP-HPLC, Validation, Accuracy, Precision.